A survey co-released Wednesday by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.
Teva Pharmaceutical Industries on Thursday announced that the U.S. Court of Appeals for the Federal Circuit upheld a ruling by the U.S. District Court for the District of Delaware finding Bristol-Myers Squibb's entecavir compound claim of U.S. Patent No. 5,206,244 invalid.
Valeant Pharmaceuticals International announced that its subsidiary, Valeant Pharmaceuticals North America, received approval from the Food and Drug Administration for its new drug application for Jublia (efinaconazole 10% topical solution). The drug is the first topical triazole approved for the treatment of onychomycosis of the toenails, the company said.
A recently approved drug might make infusions for hemophiliacs fewer and further between. The Food and Drug Administration approved Biogen Idec's Eloctate, which clinical trials have shown works to treat bleeding episodes and to increase the time between prophylactic blood infusions for those with hemophilia A.
Upsher-Smith Laboratories on Wednesday announced that it has received final approval from the Food and Drug Administration for its new drug application for Vogelxo (testosterone) gel for topical use CIII.
Indian drug maker Wockhardt has been charged by the Food and Drug Administration with utilizing the same unapproved method to test drug quality in its Morton Grove, Ill., facility as two facilities in India, both of which were subsequently banned from importing into the United States,the Wall Street Journal reported Tuesday.
Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.
Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.
Trimel Pharmaceuticals on Wednesday announced that the Food and Drug Administration has approved Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Teva Pharmaceutical on Friday announced that the Food and Drug Administration approved the use of QVAR (beclomethasone dipropionate HFA) with a dose counter for the treatment of asthma in patients 5 years of age and older.