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Latest Abbreviated New Drug Application Stories

2014-09-15 12:27:53

DUBLIN, Sept. 15, 2014 /PRNewswire/ -- Research and Markets has announced the addition of the "Closed Drug Transfer Systems to 2020" report to their offering. http://photos.prnewswire.com/prnvar/20130307/600769 The administration of drugs deemed hazardous to humans has been receiving increasing amounts of scrutiny in recent years as the dangers of these substances become more clearly understood. For caregivers and their patients, the therapeutic area that is at the forefront of attempts to...

2014-09-10 23:08:02

The Alabama Supreme Court ruled that brand-name drug companies can be sued for injuries caused by its generic equivalent if the brand-name manufacturer made misleading or inaccurate claims about the drug, and those claims were relied upon by the injured person’s physician; this decision confirms the court’s previous ruling last year. Port Washington, New York (PRWEB) September 10, 2014 Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by...

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)....

2014-08-22 23:08:21

For generic drugmakers, Oct. 1 is crunch time and is the date after which all ANDA amendment and prior-approval supplement applications must meet new performance goals under the Generic Drug User Fee Amendments (GDUFA) of 2012. Joan Janulis, a Hatch-Waxman pro and all-around expert on FDA regulation in the generic drug industry, will help attendees read between the lines of the GDUFA performance metrics, associated guidance documents and MAPPs, and provide a roadmap to the post-GDUFA...

2014-08-05 23:03:14

OMICS Group International schedules its 5th World Congress on Bioavailability and Bioequivalence: Pharmaceutical R&D Summit during September 29 to October 01, 2014 at Baltimore, USA with an aim to Revolutionize the Next Generation Medicines using innovative Bioavailability and Bioequivalence (BA/BE) approaches and Studies. Los Angeles, CA (PRWEB) August 05, 2014 Speaking for this occasion, CEO of the OMICS Group International, Dr. Srinubabu Gedela observed that several high profile...

2014-07-11 16:23:31

DUBLIN, July 11, 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 Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release tablets, 10 mg/10 mg. Actavis' ANDA product is a generic version of Duchesnay Inc.'s Diclegis(®), which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to...

2014-06-24 23:14:41

There are several common mistakes in ANDA submissions that can be avoided to ensure speedy approval. Learn what those mistakes are and what to do about them on July 15 at the FDAnews webinar led by 30-year industry expert Dr. Andy Papas, Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech. Falls Church, VA (PRWEB) June 24, 2014 Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time **FDAnews Webinar** July 15, 2014 — 1:30 p.m. – 3:00...

2014-06-20 08:23:55

BUENA, N.J., June 20, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted two additional abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to six, with seventeen submissions now pending at the FDA. http://photos.prnewswire.com/prnvar/20130827/MM70487LOGO Jason Grenfell-Gardner,...

2014-06-19 08:28:55

BUENA, N.J., June 19, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted another abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to four, with fifteen submissions now pending at the FDA. http://photos.prnewswire.com/prnvar/20130827/MM70487LOGO Jason Grenfell-Gardner,...

2014-06-18 08:29:26

BUENA, N.J., June 18, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its third abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions to sixteen, with fourteen now pending at the FDA. http://photos.prnewswire.com/prnvar/20130827/MM70487LOGO Jason Grenfell-Gardner, President and...


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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.