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Last updated on April 16, 2014 at 4:43 EDT

Latest Abbreviated New Drug Application Stories

2014-04-15 08:29:42

DUBLIN, April 15, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has entered into an agreement with Mylan Inc. and Famy Care Ltd. to settle all outstanding patent litigation related to Mylan's generic version of Generess(®) FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets). Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess(®) FE under its pending Abbreviated New Drug...

2014-03-19 16:23:48

DUBLIN, March 19, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has entered into an agreement with Noven Pharmaceuticals, Inc. to settle all outstanding patent litigation related to Actavis' generic version of Daytrana(® )(Methylphenidate Transdermal System). Daytrana(®) is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder. Under the terms of the agreement, Noven will grant Actavis a non-exclusive, royalty-bearing...

2014-03-17 08:29:38

View the White Paper at: www.expectad.com/wp.pdf CLIFTON, N.J., March 17, 2014 /PRNewswire-iReach/ -- In an ongoing effort to promote the usage of FDA-approved drugs, Medicast, Inc., a medicaleducation organization, has released a White Paper -- The Hazards of Unapproved Drugs and Importance of Utilizing Approved Drugs. (Photo: http://photos.prnewswire.com/prnh/20140317/MN84069) The White Paper was developed by a leading hospital pharmacist - Cindy Ippoliti, Pharm.D., NYP/Weill...

2014-03-12 12:29:30

BUENA, N.J., March 12, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has received its first approval from the U.S. Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA). The FDA has approved IGI's application for lidocaine hydrochloride USP 4% topical solution. http://photos.prnewswire.com/prnvar/20130827/MM70487LOGO Lidocaine hydrochloride USP 4% topical solution...

2014-03-03 16:25:55

BUENA, N.J., March 3, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its first 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 fourteen. http://photos.prnewswire.com/prnvar/20130827/MM70487LOGO Jason Grenfell-Gardner, President and CEO of the Company, commented, "We now...

2013-12-31 12:22:30

BUENA, N.J., Dec. 31, 2013 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it executed a license, development, supply and marketing agreement with a large multi-national pharmaceutical company. In accordance with the confidentiality agreement in place, the name of the company remains undisclosed. The agreement designates IGI Laboratories, Inc. (IGI) as the developer and manufacturer of a generic...

2013-12-24 08:24:08

DUBLIN, Dec. 24, 2013 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal Ring, 0.015 mg/24 hour and 0.12 mg/24 hour. Actavis' ANDA product is a generic version of Merck & Co.'s NuvaRing(®), which is an estrogen/progestin combination hormonal...

2013-12-05 20:22:04

FALLS CHURCH, Va., Dec. 5, 2013 /PRNewswire-iReach/ -- FDA's New Generic Drug Safety Labeling Rule **FDAnews Webinar** Dec. 9, 2013 -- 1:30 p.m. - 3:00 p.m. EST http://www.fdanews.com/GenericSafetyLabeling (Photo: http://photos.prnewswire.com/prnh/20131205/MN28375) The FDA's new proposed rule allowing generic manufacturers, for the first time, to use the CBE-0 process to unilaterally change labels represents a paradigm shift in managing warnings, product liability and pharmacovigilance. The...

2013-12-04 23:28:49

The FDA’s new proposed rule allowing generic manufacturers, for the first time, to use the CBE-0 process to unilaterally change labels represents a paradigm shift in managing warnings, product liability and pharmacovigilance. Falls Church, VA (PRWEB) December 04, 2013 FDA’s New Generic Drug Safety Labeling Rule **FDAnews Webinar** Dec. 9, 2013 — 1:30 p.m. – 3:00 p.m. EST http://www.fdanews.com/SafetyLabeling The biggest concern for generics firms? A potential surge in liability...

2013-11-14 08:34:10

DUBLIN, Nov. 14, 2013 /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 Testosterone Topical Solution, 30mg/1.5mL. Actavis' ANDA product is a generic version of Eli Lilly and Company's Axiron(®), which is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous...