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Last updated on April 19, 2014 at 18:42 EDT

Latest New Drug Application Stories

2014-04-16 08:34:30

HAYWARD, Calif., April 16, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it is commencing shipment of authorized generic RENVELA (sevelamer carbonate 800 mg tablets), through Global Pharmaceuticals, Impax's generics division. RENVELA is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. http://photos.prnewswire.com/prnvar/20140402/PH96035LOGO Under the terms of a settlement agreement, Genzyme,...

2014-04-15 08:30:06

Purchase adds global regulatory writing and submission services to Certara's drug development consulting expertise NEW YORK, April 15, 2014 /PRNewswire/ -- Arsenal Capital Partners, a leading New York based private equity firm that invests in middle market healthcare, specialty industrial, and financial services companies, announced today the acquisition of Synchrogenix, the leading regulatory writing and related services firm. Synchrogenix provides services to pharmaceutical,...

2014-04-14 12:33:11

PDUFA goal date set for September 26, 2014 ATLANTA, April 14, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its recent resubmission of the New Drug Application (NDA) for ILUVIEN(®) has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete class 2 response to the...

2014-04-11 08:24:24

HAYWARD, Calif., April 11, 2014 /PRNewswire/ -- Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration (FDA). IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson's disease (PD). After discussions with the FDA, the Company has...

2014-04-04 23:29:56

MannKind's AFREZZA takes a big step towards FDA approval. Princeton, NJ (PRWEB) April 03, 2014 PharmApprove, the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries, congratulates client MannKind Corporation on its successful U.S. Food and Drug Administration (FDA) Endocrine and Metabolic Advisory Committee meeting this week. The committee voted 13 to 1 on April 1 to recommend that MannKind’s AFREZZA® (insulin...

2014-04-03 08:29:04

-- Phase 2 Clinical Trial Planned to Begin This Quarter -- SEATTLE, April 3, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement?mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration (FDA). OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2),...

2014-04-01 16:25:48

CUPERTINO, Calif., April 1, 2014 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that data for POSIDUR((TM)) (SABER(®)-Bupivacaine), an investigational drug for administration into the surgical site to produce post-surgical analgesia, is being presented at the 39(th) Annual American Society of Regional Anesthetic and Pain Medicine Meeting. The meeting will be held on April 3-6 at the Sheraton Chicago Hotel and Towers in Chicago....

2014-03-27 08:34:36

AVP-825 relies on novel closed palate Breath Powered(TM) drug delivery technology YARDLEY, Pa., March 27, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for AVP-825, an innovative closed-palate Breath Powered(TM) investigational drug-device combination product for the acute treatment of migraine. As previously reported, the 505(b)(2) NDA for AVP-825 includes clinical data developed by OptiNose including a pivotal phase...

2014-03-26 08:30:13

ALISO VIEJO, Calif., March 26, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) of AVP-825, its innovative Breath Powered(TM) investigational drug-device combination product for the acute treatment of migraine. http://photos.prnewswire.com/prnvar/20130207/LA55901LOGO As previously reported the company's 505(b)(2) NDA for AVP-825 includes data from...

2014-03-24 12:31:14

PITTSBURGH, March 24, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced the United States District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist® (formoterol fumarate) Inhalation Solution. Mylan previously sued Teva alleging that Teva's Abbreviated New Drug Application (ANDA) for this product infringed four Mylan patents covering Perforomist. After a full trial, the Court...