Drugs and Diseases » NewDrugs

Discovery Labs Submits Surfaxin Complete Response to FDA

admin — Fri, 09 Sep 2011 09:59:41 +0000

WARRINGTON, Pa., Sept. 6, 2011 /PRNewswire/ — Discovery Labs,
Inc. today announced that, on September 2, 2011, it
submitted its Complete Response to the 2009 Complete Response
Letter issued by the U.S. Food and Drug Administration (FDA)…

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Discovery Labs Submits Surfaxin Complete Response to FDA

admin — Fri, 09 Sep 2011 09:00:04 +0000

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VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction

admin — Mon, 05 Sep 2011 13:59:41 +0000

MOUNTAIN VIEW, Calif.,
Sept. 1, 2011 /PRNewswire/ — VIVUS,
Inc. today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review the company’s new drug
application (NDA) for its investigational drug candidate,…

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VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction

admin — Mon, 05 Sep 2011 13:00:17 +0000

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VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction

admin — Mon, 05 Sep 2011 12:59:44 +0000

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Baxter Announces FDA Approval of Artiss Fibrin Sealant for Use in Face-Lift (Facial Rhytidectomy) Procedures

admin — Wed, 31 Aug 2011 13:08:56 +0000

DEERFIELD, Ill.–(BUSINESS WIRE)–Aug 31, 2011 – Baxter
International Inc. announced today that the U.S. Food and Drug
Administration (FDA) has expanded the indication of Artiss [Fibrin
Sealant (Human)] to include adhering tissue flaps during…

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Astellas Pharma Inc.: Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe

admin — Wed, 31 Aug 2011 10:59:47 +0000

TOKYO, Aug. 28, 2011 /PRNewswire/ –Astellas Pharma Inc. today announced the submission of a New
Drug Application and Market Authorisation Application for
mirabegron (generic name / code name: YM178) to the U.S. Food and
Drug Administration and…

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FDA Requests Additional Clinical Data on Novartis Drug ACZ885 for the Treatment of Gouty Arthritis

admin — Wed, 31 Aug 2011 10:59:47 +0000

Basel, August 29, 2011 – Novartis has received a Complete
Response letter from the US Food and Drug Administration (FDA) as
part of the US regulatory review for ACZ885 (canakinumab) in gouty
arthritis patients. In its letter, the FDA requested…

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QRxPharma Completes NDA Submission for MoxDuo IR

admin — Wed, 31 Aug 2011 10:59:44 +0000

SYDNEY and BEDMINSTER, N.J., Aug. 25, 2011 /PRNewswire/ –
QRxPharma Limited announced today
submission of its New Drug Application (NDA) clinical data package
to the United States Food and Drug Administration (FDA) for MoxDuo
IR, an…

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FDA Requests Additional Information Regarding NuPathe’s Migraine Patch in Complete Response Letter

admin — Tue, 30 Aug 2011 15:08:21 +0000

CONSHOHOCKEN, PA — (Marketwire) — August 30, 2011 — NuPathe
Inc. today announced that it has received a
Complete Response Letter (CRL) from the U.S. Food & Drug
Administration (FDA) regarding the New Drug Application (NDA) for
its migraine…

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FDA Approves Xalkori with Companion Diagnostic for a Type of Late-Stage Lung Cancer

admin — Fri, 26 Aug 2011 23:08:27 +0000

August 26, 2011 – The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma…

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Nucynta ER (Tapentadol Extended-Release Tablets) Receives FDA Approval for the Management of Moderate to Severe Chronic Pain

admin — Fri, 26 Aug 2011 14:08:45 +0000

Raritan, N.J., August 26, 2011 /PRNewswire/ — Janssen
Pharmaceuticals, Inc. today announced the U.S. Food and Drug
Administration (FDA) has approved Nucynta ER, an oral
analgesic taken twice daily, for the management of moderate to
severe…

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Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date

admin — Fri, 26 Aug 2011 07:59:45 +0000

CARMIEL, Israel, Aug. 17, 2011–Protalix BioTherapeutics, Inc.
announced today that the U.S. Food &
Drug Administration (FDA) has accepted for review the resubmission
of the taliglucerase alfa New Drug Application (NDA) following the
Company’s…

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FDA Approves Shire’s Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE)

admin — Thu, 25 Aug 2011 17:08:28 +0000

DUBLIN, Ireland and LEXINGTON, Massachusetts, August 25,
2011 — Shire plc, the global specialty biopharmaceutical company, today announced
that the U.S. Food and Drug Administration (FDA) has granted
marketing approval for Firazyr (icatibant…

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Alexza Announces Adasuve Staccato (Loxapine) PDUFA Goal Date of February 4, 2012

admin — Thu, 25 Aug 2011 01:35:47 +0000

MOUNTAIN VIEW, Calif., Aug. 19, 2011 /PRNewswire/ — Alexza
Pharmaceuticals, Inc. announced today that the U.S.
Food & Drug Administration (FDA) has accepted the Adasuve New
Drug Application (NDA) as a complete, class 2 response to the…

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