Actavis seeks FDA ANDA acceptance for generic Zubsolv.

Patents. The lawsuit was filed beneath the provisions of the Hatch-Waxman Act, producing a stay of last FDA authorization of Actavis' ANDA for 30 months from the time the plaintiffs received see of Actavis' ANDA filing or until final resolution of the problem before the court, whichever occurs sooner, subject to any other exclusivities.. Actavis seeks FDA ANDA acceptance for generic Zubsolv, confirms patent challenge Actavis plc today confirmed that it offers filed an Abbreviated New Medication Program with the U.S. Food and Medication Administration seeking acceptance to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Foundation. Related StoriesMylan sued in connection with ANDA submitting for generic edition of ZytigaMylan announces U.S.The letter, which was signed by Dr. Homayoon Khanlou, Chief of Michael and Medication/US Weinstein, AHF President, stated: This letter can be to see you that effective instantly, Merck sales representatives are no more granted usage of these [AHF Healthcare] centers. As AHF has described to Merck regarding this matter repeatedly, there is absolutely no justification for Isentress to be priced as a salvage medication now that the FDA provides accepted it for first-line use, increasing its market vastly. It is real greed.