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Last updated on April 24, 2014 at 1:21 EDT

Latest Drug Price Competition and Patent Term Restoration Act Stories

2014-02-28 16:23:59

DUBLIN, Feb. 28, 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 Colchicine Tablets USP, 0.6 mg. Actavis' ANDA product is a generic version of Takeda's Colcrys(®), which is a prescription medicine used in adults to prevent and treat gout flares. Takeda Pharmaceuticals U.S.A., Inc. filed suit against Actavis on February 27, 2014 in the...

2014-02-28 08:25:23

DUBLIN, Feb. 28, 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 Dronedarone Hydrochloride Tablets 400 mg. Actavis' ANDA product is a generic version of Sanofi's Multaq(®), which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of...

2014-02-04 08:34:45

DUBLIN, Feb. 4, 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 Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial. Actavis' ANDA product is a generic version of Cephalon's Treanda(®), a treatment for chronic lymphocytic leukemia and non-Hodgkin's lymphoma. Cephalon, Inc. filed suit against Actavis on January 31,...

2014-01-29 12:28:09

WASHINGTON, Jan. 29, 2014 /PRNewswire-USNewswire/ -- "In last night's State of the Union address, President Obama said, 'Today in America... [a]rural doctor gave a young child the first prescription to treat asthma that his mother could afford,' vividly capturing the critical importance of access to safe, affordable medicines for our nation's patients and our health care system. Indeed, in the 30 years since the enactment of the enormously successful Hatch-Waxman law in 1984, which...

2014-01-14 08:23:03

WASHINGTON, Jan. 14, 2014 /PRNewswire/ -- Sterne, Kessler, Goldstein & Fox P.L.L.C., an intellectual property law firm based in Washington, DC, recently announced the election of four new directors - Paul A. Ainsworth, Salvador M. Bezos, Carla Ji-Eun Kim, and Lei Zhou- effective January 1, 2014. -- Paul A. Ainsworth is a director in the Litigation Practice Group. He represents clients in litigation in a diverse range of technologies and has extensive experience...

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...

2013-11-14 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...

2013-10-31 08:34:43

DUBLIN, Oct. 31, 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 Isotretinoin Capsules, 10 mg, 20 mg, 30 mg and 40 mg. Actavis' ANDA product is a generic version of Ranbaxy Inc.'s Absorica(®), which is a retinoid indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older. Cipher...

2013-10-28 08:29:15

DUBLIN, Oct. 28, 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 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%. Actavis' ANDA product is a generic version of Dow Pharmaceutical Sciences and Valeant Pharmaceuticals International's Acanya(®) Gel, which is indicated for the topical treatment of acne vulgaris in patients 12...

2013-10-08 16:25:14

DUBLIN, Oct. 8, 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 Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Film 2 mg/0.5 mg and 8 mg/2 mg. Actavis' ANDA product is a generic version of Reckitt Benckiser's Suboxone(®) Sublingual Film, which is indicated for maintenance treatment of opioid dependence. Reckitt...