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Latest New Drug Application Stories

2014-09-17 08:31:00

HAYWARD, Calif., Sept. 17, 2014 /PRNewswire/ -- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the RYTARY(TM) (IPX066) New Drug Application (NDA) from October 9, 2014, to January 9, 2015. The Company amended the chemical, manufacturing and control (CMC) section of the RYTARY NDA subsequent to...

2014-09-15 08:28:36

MONMOUTH JUNCTION, N.J., Sept. 15, 2014 /PRNewswire/ -- Vernalis plc (LSE: VER) and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has confirmed that the New Drug Application ("NDA") for Tuzistra(TM) XR ("CCP-01") has been accepted for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015. Under...

2014-08-28 12:29:56

PITTSBURGH, Aug. 28, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its abbreviated new drug application (ANDA) for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration (FDA). This product is the generic version of Teva's Copaxone® 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS)....

2014-08-27 08:28:22

THOUSAND OAKS, Calif., Aug. 27, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the I(f) current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.(1) Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular...

2014-08-22 16:23:24

DUBLIN, Aug. 22, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Rotigotine Extended-release Transdermal Film, 1 mg/24 hr, 2mg/24 hr, 3 mg/24hr, 4 mg/24 hr, 6mg/24hr, and 8 mg/24 hr. Actavis' ANDA product is a generic version of UCB's Neupro(®), which is indicated for the treatment of signs and symptoms of idiopathic Parkinson's...

2014-08-12 08:29:19

BEMA Buprenorphine on track for late 2014 or early 2015 NDA filing by partner Endo Pharmaceuticals RALEIGH, N.C., Aug. 12, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that along with its commercial partner, Endo Pharmaceuticals, engaged in a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding BEMA Buprenorphine for the management of pain severe enough to require daily, around-the-clock,...

2014-08-06 16:28:59

-- Transformational H1 2014 includes presentation of Phase 3 ASCEND data, NDA resubmission and target PDUFA date of Nov. 23 for pirfenidone in U.S. - BRISBANE, Calif., Aug. 6, 2014 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced results from operations for the second quarter ended June 30, 2014. The company also highlighted recent clinical development and business highlights, and updated its forward-looking financial guidance for 2014. InterMune reported Esbriet(®)...

2014-08-05 16:27:45

Jazz Pharmaceuticals owns worldwide rights to defibrotide DUBLIN, Aug. 5, 2014 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the closing of its acquisition of rights to defibrotide in the United States (U.S.) and all other countries in the Americas from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau). Jazz Pharmaceuticals now owns worldwide rights to defibrotide. Defibrotide is a novel product that is marketed by Jazz Pharmaceuticals in the European Union (EU)...

2014-08-04 08:28:51

HAYWARD, Calif., Aug. 4, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a re-inspection of the Company's Hayward, California manufacturing facility from June 16 to July 31, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations. The FDA did not provide any status or classification to these...

2014-07-29 08:32:31

HAYWARD, Calif., July 29, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARY(TM )at the Company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in...


Word of the Day
omadhaun
  • A fool; a simpleton: a term of abuse common in Ireland and to a less extent in the Gaelic-speaking parts of Scotland.
This word is partly Irish in origin.