http://www.biospace.comBioSpace RSS GeneratorWed, 19 Jun 2013 05:32:11 GMT20http://rss.biospace.com/images/BSPLogo.gifhttp://www.BioSpace.com/news.aspx?SectionId=1Copyright (C) 2011http://www.biospace.com/news_story.aspx?StoryID=136700&full=1<div id"releaseBody"><p>SOUTH SAN FRANCISCO, CA--(Marketwire - April 24, 2009) - Theravance, Inc. (NASDAQ: <a href"http://www.marketwire.com/mw/stock.jsp?TickerTHRX">THRX</a>)announced today that the U.S. Food and Drug Administration (FDA) acceptedas complete for review Theravance's response to the February 2009 CompleteResponse letter, which outlined requirements for approval of telavancin...Mon, 27 Apr 2009 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idINBNG12462220080924?rpc=44Sept 24 (Reuters) - Discovery Laboratories Inc said it expects to submit a complete response to the U.S. Food and Drug Administration's concerns on its experimental lung drug for infants within the next four weeks.Wed, 24 Sep 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=106432&full=1<p> VANCOUVER and DEERFIELD, IL, Aug. 11 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that they have received an action letter dated August 8, 2008 from the U.S. Food and Drug Administration (FDA) for KYNAPID(TM) (vernakalant hydrochloride) Injection for the treatment of atrial fibrillation (AF) - a potentially...Mon, 11 Aug 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=105929&full=1WARRINGTON, Pa., Aug. 6, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces that it has made significant progress in addressing key remaining requirements identified by the U.S. Food and Drug Administration (FDA) to gain marketing approval of Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Over the upcoming weeks...Wed, 06 Aug 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=105005&full=1BRUSSELS, BELGIUM--(Marketwire - July 29, 2008) - 6 pm CEST - press release, regulated information: UCB announced today that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for lacosamide for the treatment of diabetic neuropathic pain in adults. </p><p>The company will seek clarification from the FDA of its position and of the additional information required...Wed, 30 Jul 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=104691&full=1<p> WOODCLIFF LAKE, N.J., July 25 /PRNewswire/ -- Eisai Corporation of North America today announced that it has received a not approvable letter from the U.S. Food and Drug Administration (FDA), which outlines a pathway to potential approval of fospropofol disodium for use by appropriately trained physicians. Fospropofol disodium injection has been in review at the FDA for use as an intravenous...Mon, 28 Jul 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idINBNG26037620080728?rpc=44<p> ROCKVILLE, Md., July 28 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. announced today the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia.</p><p> The FDA stated that Vanda had demonstrated the effectiveness...Mon, 28 Jul 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=104194&full=1EAST WINDSOR, N.J.--(BUSINESS WIRE)--NexMed, Inc. (Nasdaq: NEXM - News), today announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for erectile dysfunction (ED). The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which...Wed, 23 Jul 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=104022&full=1NEWPORT, Ky.--(BUSINESS WIRE)--Xanodyne Pharmaceuticals, Inc. announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zipsor, its candidate for the treatment of patients with mild to moderate acute pain. Zipsor is a proprietary immediate release liquid-filled soft gelatin capsule containing 25 mg of diclofenac potassium for oral administration...Tue, 22 Jul 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=103588&full=1ATLANTA--(BUSINESS WIRE)--Sciele Pharma, Inc. (NASDAQ:SCRX - News) today announced that the U.S. Food & Drug Administration (FDA) has issued an approvable letter for the head lice treatment. Sciele Pharma is working closely with Summers Laboratories and the FDA to provide additional information that was requested.</p><p>About Sciele Pharma, Inc.</p><p>Sciele Pharma, Inc. is a pharmaceutical...Thu, 17 Jul 2008 12:00:00 AM GMThttp://www.nytimes.com/2008/07/10/business/10drug.html?ref=businessThe U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. <br><br>Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved...Thu, 10 Jul 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=101898&full=1<p> LEXINGTON, Mass., June 30 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for NEBIDO(R) related to a New Drug Application (NDA) submitted to the FDA in August 2007. The letter, received on June 27, 2008, indicated that the application may be approved if the Company is able to...Mon, 30 Jun 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=100817&full=1PHILADELPHIA, June 18, 2008 (PRIME NEWSWIRE) -- Eurand N.V. (NasdaqGM:EURX - News), a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the Company...Thu, 19 Jun 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idINBNG21521420080619?rpc=44WARRINGTON, Pa., June 19, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (NasdaqGM:DSCO - News) held a teleconference on June 18, 2008 with the U.S. Food and Drug Administration (FDA) to discuss Discovery Labs' approach to addressing key remaining items identified in the May 1, 2008 Approvable Letter to potentially gain U.S. marketing approval of SURFAXIN(r) (lucinactant) for the prevention...Thu, 19 Jun 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=98929&full=1STOCKHOLM, Sweden--(BUSINESS WIRE)--Regulatory News:The U.S. Food and Drug Administration (FDA) has requested more information on Medas new drug application concerning azelastine hydrochloride nasal spray in a new formulation. Meda will initiate a discussion with the FDA to understand and clarify the needs of FDA and what steps need to be taken before the application may be approved. This process...Wed, 04 Jun 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=98250&full=1<p> COLLEGEVILLE, Pa., May 29 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the first-in-class antibiotic TYGACIL(R) (tigecycline) for the treatment of adult patients with community-acquired pneumonia (CAP).</p><p> Before granting approval, the FDA requested that Wyeth...Thu, 29 May 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=98137&full=1WARRINGTON, Pa., May 29, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (NasdaqGM:DSCO - News), announced that it has received written notification from the U.S. Food and Drug Administration (FDA) that a meeting has been scheduled for June 18, 2008 via teleconference. This meeting is intended to confirm with the FDA Discovery Labs' approach to address the limited key remaining items necessary...Thu, 29 May 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUSN237121620080523COLLEGEVILLE, Pa., May 23 /PRNewswire/ -- Wyeth Pharmaceuticals, adivision of Wyeth (NYSE: WYE), announced today that the U.S. Food and DrugAdministration (FDA) issued an approvable letter on May 21 for bazedoxifene, aselective estrogen receptor modulator, for the treatment of postmenopausalosteoporosis. In the letter, the FDA requested information similar to thatoutlined in its approvable...Fri, 23 May 2008 12:00:00 AM GMThttp://www.forbes.com/feeds/ap/2008/05/05/ap4968434.html?partner=alertsWARRINGTON, Pa., May 5, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (NasdaqGM:DSCO - News) on May 1, 2008 received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Discovery Labs' Manufacturing, Quality and Regulatory management have performed an assessment of...Mon, 05 May 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idINN0246323820080502?rpc=44NEW YORK, May 2 (Reuters) - The U.S. Food and Drug Administration declined to immediately approve Discovery Laboratories Inc's drug to help prevent respiratory distress syndrome in premature babies, the company said on Friday, sending shares down 41 percent.Fri, 02 May 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idINN2819983520080428?rpc=44WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today received a Not Approvable action letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.</p><p>"We plan to meet with the FDA and to submit additional information to enable the...Tue, 29 Apr 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idINN2539829720080426?rpc=44KENILWORTH and WHITEHOUSE STATION, N.J., April 25 /PRNewswire/ -- Schering-Plough/MERCK Pharmaceuticals (SPM) today confirmed that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for a proposed fixed combination of loratadine and montelukast for the treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion.</p><p>The New Drug...Mon, 28 Apr 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=93924&full=1BERLIN, April 24, 2008 (PRIME NEWSWIRE) -- Jerini AG (FSE:JI4) announced today that the company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for Icatibant in the treatment of acute attacks of hereditary angioedema (HAE). The committee will now recommend that the European Commission grant marketing authorization...Fri, 25 Apr 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKL1864001220080318?rpc=44<p> RARITAN, N.J., March 18 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.</p><p> J&JPRD...Tue, 18 Mar 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idINT26342020080314?rpc=44TOKYO (Reuters) - Japan's Astellas Pharma Inc said on Friday that U.S. authorities have requested more information on its key kidney transplant drug Advagraf, meaning it will face further delays in receiving approval there.Fri, 14 Mar 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKL1267220220080312?rpc=44TOKYO, March 12 (Reuters) - U.S. regulators have rejected Daiichi Sankyo Co Ltd's injectable anaemia drug Injectafer for the broad treatment of uterine bleeding and in a surprise move also knocked it back for a narrower use.Wed, 12 Mar 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKBNG8861120080305?rpc=44SOUTH SAN FRANCISCO, CA--(MARKET WIRE)--Mar 5, 2008 -- Theravance, Inc. (NasdaqGM:THRX - News) today announced that on March 4, 2008 the U.S. Food and Drug Administration (FDA) accepted as complete for review Theravance's response to the October 19, 2007 New Drug Application (NDA) approvable letter for telavancin. Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic...Thu, 06 Mar 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=87529&full=1INDIANAPOLIS, Feb. 28 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY - News) has received a not approvable letter from the U.S. Food and Drug Administration for Zyprexa long-acting injection (olanzapine LAI) for the treatment and maintenance treatment of schizophrenia in adults, the company announced today. Zyprexa LAI is an investigational formulation that combines the atypical antipsychotic...Thu, 28 Feb 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=87544&full=1<p> TOKYO, Feb. 27 /PRNewswire/ -- Kyowa Hakko Kogyo Co., Ltd. (President: Dr. Yuzuru Matsuda) announced that Kyowa Pharmaceutical, Inc. (New Jersey, United States), its wholly owned U.S. subsidiary, received on February 25, 2008 (local time) a Not approvable letter from the U.S. Food and Drug Administration (FDA) for istradefylline (KW-6002), its investigational drug for the treatment of Parkinson...Thu, 28 Feb 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKWNAS890520080131?rpc=44PALO ALTO, Calif., Jan. 31 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ - News) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the submission of the response by Solvay Pharmaceuticals, Inc. to the FDA approvable letter for Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules. The FDA has notified Solvay Pharmaceuticals...Fri, 01 Feb 2008 12:00:00 AM GMThttp://www.newswire.ca/en/releases/archive/February2008/01/c6246.htmlMISSISSAUGA, ON, Feb. 1 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND)today announced that it has received a written response from the U.S. Food andDrug Administration (FDA) regarding its appeal of the Agency's ApprovableLetter for CIP-TRAMADOL ER, Cipher's extended-release formulation of tramadol.In the response, the Acting Director of the Office of Drug Evaluation II,Center for Drug Evaluation...Fri, 01 Feb 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=84284&full=1HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL - News) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its new drug application (NDA) and subsequent submissions for Vadova (carbidopa/levodopa extended release) tablets. The FDAs action was primarily based on unresolved issues relating to product nomenclature...Wed, 30 Jan 2008 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=83960&full=1WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. received a not approvable letter from the U.S Food and Drug Administration (FDA) to its New Drug Application (NDA) seeking approval for over-the-counter (OTC) MEVACOR (lovastatin) 20 mg. MEVACOR OTC had been under review by the FDA since 1999; Advisory Committee reviews in 2000 and 2005 resulted in not approvable actions.</p><p>The FDA...Mon, 28 Jan 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idCAN2426355120080124?rpc=44LAVAL, QC, Jan. 24 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding its most recent appeal of the decision in the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process. John K. Jenkins, M.D., Director...Thu, 24 Jan 2008 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKWEN315620071222?rpc=44<p> SUNNYVALE, Calif., Dec. 21 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for the company's new drug application (NDA) for Xcytrin(R) (motexafin gadolinium) Injection for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases. The NDA for use of Xcytrin in...Wed, 26 Dec 2007 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=81306&full=1NEW YORK--(BUSINESS WIRE)--Pfizer Inc today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) issued for dalbavancin HCl, Pfizers once-weekly two-dose antibiotic under FDA review for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA)....Wed, 26 Dec 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKWNAS526520071221?rpc=44<p> PALO ALTO, Calif., Dec. 21 /PRNewswire-FirstCall/ -- Today, Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for Once-A-Day LUVOX(R) CR (fluvoxamine maleate) Extended-Release Capsules, for which Jazz Pharmaceuticals and Solvay Pharmaceuticals, Inc. are seeking marketing approval for the treatment of two anxiety disorders...Wed, 26 Dec 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idINN2429276420071224?rpc=44<p> COLLEGEVILLE, Pa., Dec. 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for bazedoxifene, a selective estrogen receptor modulator, for the prevention of postmenopausal osteoporosis.</p><p> In its letter, the FDA identified several remaining questions regarding issues...Wed, 26 Dec 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKBNG22004120071219?rpc=44<p> LEXINGTON, Mass., Dec. 19 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for VALSTAR(TM) related to its chemistry, manufacturing and controls (CMC) NDA supplement submitted to the FDA in May 2007. The letter was received following the Company's response to an August 2007 approvable...Thu, 20 Dec 2007 12:00:00 AM GMThttp://www.reuters.com/article/rbssHealthcareNews/idUSN1364737720071213<p> SAN DIEGO, Dec. 13 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. announced today that the Company has received communication from the U.S. Food and Drug Administration (FDA) indicating that the New Drug Application (NDA) for indiplon 5 mg and 10 mg capsules for the treatment of insomnia is approvable pending additional clinical and preclinical data.</p><p> On May 15, 2006, the Company...Thu, 13 Dec 2007 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=79924&full=1LONDON, UK, 10 December 2007-- SkyePharma PLC (LSE: SKP) today announces that the United States Food and Drug Administration (FDA) has issued an approvable letter for GlaxoSmithKlines (NYSE:GSK) Requip XL Extended Release tablets. An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.</p...Mon, 10 Dec 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKWEN276520071202?rpc=44NEW YORK and PITTSBURGH, Dec. 2 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX - News) and Mylan Inc. (NYSE: MYL - News) announced that Mylan has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for nebivolol (proposed brand name Bystolic(TM)), a novel beta blocker under review for the treatment of hypertension...Mon, 03 Dec 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKN2111348320071121?rpc=44TORONTO, Nov 21 (Reuters) - Labopharm Inc (DDS.TO: Quote, Profile, Research) said on Wednesday the U.S. Food and Drug Administration responded to its appeal of the approvable letter for its once-daily tramadol, and that the agency will not overturn the letter, which was issued in May.Mon, 26 Nov 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKN2111348320071121?rpc=44<p> LAVAL, QC, Nov. 21 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding its appeal of the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process. In the response, the Acting Director of the Office of Drug Evaluation II, Center for Drug...Wed, 21 Nov 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKL0357870220071103?rpc=44<p> HOUSTON, LONDON and RESEARCH TRIANGLE PARK, N.C., Nov. 2 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals Inc. (FKP) and GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the new drug application for gepirone extended- release (ER) tablets, submitted for the treatment of adults with major depressive disorder.</p><p> The FDA...Mon, 05 Nov 2007 12:00:00 AM GMThttp://biz.yahoo.com/bw/071101/20071101006065.html?.v=1CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ:POZN - News) announced today that its amended response to the FDA approvable letter for Trexima received on August 1, 2007 has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has also notified POZEN that it considers the submission to be a complete, Class II response (six months) which could result in a new decision...Thu, 01 Nov 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKBNG7697420071029?rpc=44CHESTER, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Adams Respiratory Therapeutics, Inc. (Nasdaq: ARxT - News) today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter related to the New Drug Application (NDA) for Mucinex with Codeine (guaifenesin 600/1200 mg and codeine phosphate 30/60 mg) extended-release bi-layer tablets. The approvable letter relates to the...Mon, 29 Oct 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKWNAS771320071023?rpc=44MIAMI--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc. (NASDAQ:NOVN - News) today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter related to the New Drug Application (NDA) for Stavzor (delayed release valproic acid capsules) in 125mg, 250mg and 500mg strengths. The approvable letter relates to the use of Stavzor in the treatment of manic episodes associated...Wed, 24 Oct 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKWNAS723320071022?rpc=44SOUTH SAN FRANCISCO, CA and DEERFIELD, IL--(MARKET WIRE)--Oct 22, 2007 -- Theravance, Inc. (NasdaqGM:THRX - News) and Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter for telavancin, a novel bactericidal, once-daily injectable antibiotic discovered by Theravance, for the treatment of complicated skin and skin structure infections...Mon, 22 Oct 2007 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=73996&full=1EWING, NJ--(MARKET WIRE)--Oct 19, 2007 -- DOR BioPharma, Inc. (OTC BB:DORB.OB - News) ("DOR," or "Company") announced today that it has received a not approvable letter from the US Food and Drug Administration (FDA) for its lead product orBec (oral beclomethasone dipropionate, or oral BDP) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life...Fri, 19 Oct 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKN1535314320071015?rpc=44<p> LAVAL, QC, Oct. 15 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that it has initiated the U.S. Food and Drug Administration (FDA)'s Formal Dispute Resolution process, appealing the Agency's decision regarding the Company's once-daily formulation of tramadol. Labopharm received a second Approvable Letter from the FDA for its once-daily formulation of tramadol in May of this year...Mon, 15 Oct 2007 12:00:00 AM GMThttp://home.businesswire.com/portal/site/biospace/index.jsp?epi-content=GENERIC&newsId=20071015005262&ndmHsc=v2*A1191841200000*B1192498686000*DgroupByDate*G2*J2*N1003674&newsLang=en&beanID=1229976837&viewID=news_viewCHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ:POZN) announced today that it submitted a response to the Approvable letter for Trexima received on August 1, 2007. This action comes after POZEN and GlaxoSmithKline met jointly with the U.S. Food and Drug Administration (FDA) to discuss the proposed plan for responding to the Approvable letter. Mon, 15 Oct 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKWNAS564620071005?rpc=44CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN) announced today that it plans to submit a response to the Approvable letter for Trexima received on August 1, 2007, within the next ten days. This action comes after POZEN and GlaxoSmithKline met jointly with the U.S. Food and Drug Administration (FDA) to discuss the proposed plan for responding to the Approvable letter. POZEN believes...Fri, 05 Oct 2007 12:00:00 AM GMThttp://www.marketwatch.com/news/story/endo-vernalis-set-back-extending/story.aspx?guid=%7BF3CC872F-617F-4E97-AE47-178E3F1BB744%7D&dist=hplatestCHADDS FORD, Pa., and WINNERSH, U.K., Sept. 30, 2007 -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP), and Vernalis plc (LSE: VER) today announced that the U.S. Food and Drug Administration (FDA) has identified deficiencies and asked for additional information pertaining to Endos supplemental New Drug Application (sNDA) for FROVA (frovatriptan...Mon, 01 Oct 2007 12:00:00 AM GMThttp://www.primenewswire.com/newsroom/news.html?d=127639WARRINGTON, Pa., Oct. 1, 2007 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announces that its new Surfaxin(r) (lucinactant) process validation batches have demonstrated acceptable stability at six months under Discovery Labs' comprehensive stability testing protocol. This six-month stability data will be included, along with other data and information, in a formal response to...Mon, 01 Oct 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKWNAS518520071001?rpc=44SAN DIEGO, Oct. 1 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN - News) announced today that the U.S. Food and Drug Administration (FDA) has approved the SymlinPen(TM) 120 and the SymlinPen(TM) 60 pen-injector devices for administering SYMLIN (pramlintide acetate) injection. These new pre-filled pen-injector devices feature simple, fixed dosing to improve mealtime glucose control...Mon, 01 Oct 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKL275819020070927?rpc=44ZURICH, Sept 27 (Reuters) - U.S. regulators have rejected Novartis AG's (NOVN.VX: Quote, Profile, Research) Prexige painkiller, a move that had been expected after Australia withdrew the drug on concerns over liver side-effects.Thu, 27 Sep 2007 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=67694&full=1<div><p> IRVINE, Calif., Aug. 27 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. announced today that it received a not approvable letter from the U.S. Food and Drug Administration (FDA) after completing the review of the new drug application (NDA) for the investigational drug mifamurtide (L-MTP-PE), formerly known as Junovan, for the treatment of non-metastatic osteosarcoma, a rare and often fatal...Mon, 27 Aug 2007 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=67115&full=1MARIETTA, Ga.--(BUSINESS WIRE)--Solvay Pharmaceuticals, Inc. today announced it has received an approvable letter from the U.S. Food and Drug Administration (FDA) with respect to its New Drug Application (NDA) for CREON. CREON (pancrelipase delayed-release capsules, USP) is a pancreatic enzyme for the treatment of pancreatic exocrine insufficiency as is often associated with cystic fibrosis and chronic...Mon, 20 Aug 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKWNAS230920070817?rpc=44<div><p> LEXINGTON, Mass., Aug. 17 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for VALSTAR(R). VALSTAR, a sterile solution of valrubicin for intravesical instillation, is the only product approved by the FDA for therapy of bacillus Calmette-Guerin (BCG)-refractory carcinoma...Fri, 17 Aug 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKN1028892020070810?rpc=44NEW YORK (Reuters) - U.S. regulators have concluded that GlaxoSmithKline's (GSK.L: Quote, Profile, Research) Requip CR extended-release tablets to treat moderate-to-severe primary restless legs syndrome must meet additional conditions before getting final approval, the company said on Friday.Mon, 13 Aug 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKN1044454720070810?rpc=44MARIETTA, Ga., Aug. 10 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), announced today the receipt of an action letter from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for bifeprunox, an atypical antipsychotic that was reviewed for the acute treatment of schizophrenia, as well as the maintenance...Fri, 10 Aug 2007 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=65833&full=1RESEARCH TRIANGLE PARK, N.C., Aug. 8 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK - News) announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the supplemental drug application for the 500/50 strength of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in the treatment of patients with chronic obstructive pulmonary disease...Wed, 08 Aug 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKWEN009220070802?rpc=44PALO ALTO, Calif., Aug. 2 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ - News) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the submission of the complete response by Solvay Pharmaceuticals, Inc. to the FDA approvable letter for Luvox CR (fluvoxamine maleate) extended-release capsules. The PDUFA action date is December 22, 2007....Fri, 03 Aug 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKL022205720070802?rpc=44CHAPEL HILL, N.C. and RESEARCH TRIANGLE PARK, N.C., Aug. 2 /PRNewswire/ -- POZEN Inc. (Nasdaq: POZN - News) and GlaxoSmithKline (NYSE: GSK - News) announced today that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for Trexima(TM) (sumatriptan/naproxen sodium). An approvable letter is an official notification from the FDA that contains conditions that must be satisfied...Thu, 02 Aug 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKN2442193420070724?rpc=44COLLEGEVILLE, Pa., July 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for PRISTIQ(TM) (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor (SNRI), currently under review as a treatment for moderate-to-severe vasomotor symptoms (hot flashes and...Tue, 24 Jul 2007 12:00:00 AM GMThttp://www.reuters.com/article/marketsNews/idUKN2029599420070720?rpc=44TORONTO--(BUSINESS WIRE)--Biovail Corporation (NYSE:BVF - News; TSX:BVF - News) today announced that it has received a Non-Approval letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for BVF-033, a novel once-daily salt formulation of bupropion. The main issue raised by the FDA in its letter related to the design of the pharmacokinetic studies required to support...Fri, 20 Jul 2007 12:00:00 AM GMThttp://www.reuters.com/article/health-SP/idUSN1724311220070717ECUBLENS, Switzerland, July 17 /PRNewswire-FirstCall/ - Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX - News; TSX: NRM - News), announces that the Company has received a second approvable letter from the United States Food and Drug Administration (FDA) for eprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis.</p><p>In...Wed, 18 Jul 2007 12:00:00 AM GMThttp://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070629:MTFH13597_2007-06-29_11-50-08_N29263990&type=comktNews&rpc=44LAVAL, QC, June 29 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that it has met with the U.S. Food and Drug Administration (FDA) to discuss the matters raised in the Agency's May 30, 2007 Approvable Letter for the Company's once-daily formulation of tramadol. The Company believes that the meeting with the Agency was productive and that the statistical...Fri, 29 Jun 2007 12:00:00 AM GMThttp://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070620:MTFH12423_2007-06-20_22-11-41_N20361551&type=comktNews&rpc=44NEW YORK--(BUSINESS WIRE)--Pfizer announced today the U.S. Food and Drug Administration (FDA) issued an approvable letter for maraviroc, which is under review as a therapy for treatment-experienced patients infected with CCR5-tropic HIV-1.</p><p>We continue our discussions with the FDA to address outstanding questions and finalize the product labeling as soon as possible. Pfizer is committed to...Thu, 21 Jun 2007 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=60745&full=1BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, June 21 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has received an approvable letter from the US Food and Drug Administration (FDA) for INTUNIV (guanfacine) extended release tablets (previously referred to as SPD503), a nonstimulant selective alpha-2A-receptor agonist, which has been studied in...Thu, 21 Jun 2007 12:00:00 AM GMThttp://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070621:MTFH07129_2007-06-21_13-22-00_WNAS4471&type=comktNews&rpc=44TITUSVILLE, N.J., June 21 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced it has received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding two supplemental New Drug Applications (sNDA) for RISPERDAL (risperidone), filed on Dec. 21, 2006. The sNDAs are for the treatment of schizophrenia in adolescents ages 13-17 years...Thu, 21 Jun 2007 12:00:00 AM GMThttp://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070616:MTFH13570_2007-06-16_00-47-44_N6F305437&type=comktNews&rpc=44HOUSTON, June 15, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (NasdaqGM:ENCY - News) today announced that the Company has received its third approvable letter from the U.S. Food and Drug Administration (FDA) for THELIN(tm) (sitaxsentan sodium), which is under review for the treatment of pulmonary arterial hypertension (PAH).</p><p>In this third approvable letter, the FDA stated that...Mon, 18 Jun 2007 12:00:00 AM GMThttp://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070531:MTFH61482_2007-05-31_21-58-20_N31255658&type=comktNews&rpc=44LAVAL, QC, May 31 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS, NASDAQ: DDSS) today announced that it has received a second approvable letter from the U.S. Food and Drug Administration (FDA) for its once-daily formulation of tramadol.</p><p>In the second approvable letter (dated May 30, 2007), the FDA stated that Labopharm has not demonstrated the efficacy of its once-daily formulation of...Fri, 01 Jun 2007 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=57050&full=1BASINGSTOKE, United Kingdom, and PHILADELPHIA, May 19 /PRNewswire/ -- Shire plc (LSE: SHP - News; Nasdaq: SHPGY - News; TSX: SHQ - News) announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for SPD465 (triple-bead mixed amphetamine salts [MAS], an investigational oral stimulant intended to provide symptom control of ADHD in adults for up to 16 hours...Mon, 21 May 2007 12:00:00 AM GMThttp://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070518:MTFH60147_2007-05-18_22-56-31_N18249184&type=comktNews&rpc=44NUTLEY, N.J., May 18 /PRNewswire/ -- Roche announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for MIRCERA for the treatment of anemia associated with chronic renal failure including patients on dialysis and patients not on dialysis.</p><p> Roche has received a draft label from the FDA and expects the label to be finalized after the Cardiovascular and...Mon, 21 May 2007 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=56237&full=1<p>UNION CITY, Calif.--(BUSINESS WIRE)--Questcor Pharmaceuticals, Inc. (AMEX:QSC) announced today that it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) for H.P. Acthar Gel (repository corticotropin injection) for the treatment of infantile spasms. The letter indicates that Questcors Supplemental New Drug Application (sNDA) is not approvable in its current...Mon, 14 May 2007 12:00:00 AM GMThttp://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070511:MTFH81586_2007-05-11_20-59-41_WEN8046&type=comktNews&rpc=44WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today confirmed that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for EMEND (fosaprepitant dimeglumine) For Injection, also known as MK-0517, an investigational intravenous therapy for chemotherapy-induced nausea and vomiting (CINV).</p><p>The FDA has...Mon, 14 May 2007 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=54976&full=1MISSISSAUGA, ON, May 3 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND - News) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) pertaining to its New Drug Application (NDA) for CIP-TRAMADOL ER, the Company's once-daily formulation of tramadol.</p><p>In its letter, the FDA indicated that Cipher's application is approvable subject to the resolution...Fri, 04 May 2007 12:00:00 AM GMThttp://www.reuters.com/article/governmentFilingsNews/idUSWEN724620070427WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Apr 27, 2007 - Merck & Co., Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a non-approvable letter in response to the Company's New Drug Application (NDA) for ARCOXIA(R) (etoricoxib) for the symptomatic treatment of osteoarthritis (OA). ARCOXIA has been under review by the FDA as an investigational selective COX-2 inhibitor since...Fri, 27 Apr 2007 12:00:00 AM GMT