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Latest Abbreviated New Drug Application Stories

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...

2014-06-09 12:31:09

ATLANTA, June 9, 2014 /PRNewswire/ -- Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, announces the approval of an Abbreviated New Drug Application (ANDA)(1) for Tranexamic Acid Injection 1000 mg/10mL (100 mg/mL). The Food and Drug Administration (FDA) determined that Acella's ANDA is bioequivalent - therefore, therapeutically equivalent - to the reference listed drug, CYKLOKAPRON® - Tranexamic Acid Injection Solution (Pharmacia & Upjohn, Inc.). Tranexamic Acid...

2014-06-02 08:29:47

BUENA, N.J., June 2, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its second 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 fifteen, with thirteen now pending at the FDA. http://photos.prnewswire.com/prnvar/20130827/MM70487LOGO Jason Grenfell-Gardner, President and...

2014-05-27 16:25:33

DUBLIN, May 27, 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 Saxagliptin Hydrochloride Tablets, 2.5 mg and 5 mg. Actavis' ANDA product is a generic version of AstraZeneca and Bristol-Myers Squibb's Onglyza(®), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes....

2014-05-12 16:29:38

LAVAL, Quebec, May 12, 2014 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) announced today that certain of its subsidiaries have entered into settlement agreements with affiliates of Actavis plc related to Actavis' generic versions of Acanya® Gel, 1.2%/2.5%, and Tiazac ® XC. Valeant's subsidiaries, Dow Pharmaceuticals Sciences, Inc. and Valeant Pharmaceuticals North America LLC, and Actavis' subsidiary, Watson Laboratories, Inc., entered into...

2014-05-12 08:31:42

DUBLIN, May 12, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has entered into an agreement with Valeant Pharmaceuticals International to settle all outstanding patent litigation related to Actavis' generic version of Acanya(® )(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%. Acanya(®) Gel is a lincosamide antibiotic and benzoyl peroxide indicated for the topical treatment of acne vulgaris. Under the terms of the agreement, Valeant will grant...


Word of the Day
glogg
  • Scandinavian punch made of claret and aquavit with spices and raisins and orange peel and sugar.
This word comes from the Swedish 'glogg,' which is an alteration of 'glodgat,' mulled (wine).
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