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An FDA advisory panel is recommending against approval of Actavis’ NDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension. Read More
European regulators have approved Eli Lilly and Boehringer Ingelheim’s insulin glargine drug Abasria, a biosimilar version of Sanofi’s blockbuster product Lantus. Read More
The FDA has cleared Takeda and Orexigen Therapeutics’ weight-loss drug Contrave, the first new anti-obesity product to win approval in more than two years. Read More
The FDA denied Teva its 180-day exclusivity period for a version of Warner Chilcott’s osteoporosis drug Actonel 150 mg because the agency itself didn’t tentatively approve Teva’s ANDA fast enough, according to an internal agency document. Read More
Beleaguered Indian generics maker Wockhardt has initiated a voluntary Class II recall of 11,661 bottles of metoprolol succinate, a generic version of AstraZeneca’s blood pressure drug Toprol-XL. Read More
Teva Pharmaceutical is pulling 3,881 bottles of a generic combination drug to treat Parkinson’s disease because the tablets are potentially “superpotent,” marking another recall for the company this year. Read More
Canadian generics maker Apotex has lost a $520 million suit that the firm brought in front of an international arbitration board against the FDA over import alerts on two of its facilities. Read More
A federal judge has ruled that Par Pharmaceutical’s generic version of the Novartis Alzheimer’s treatment Exelon Patch did not infringe on the brand manufacturer’s patent. Read More
Generic versions of Ferring Pharmaceutical’s menstrual bleeding drug Lysteda can move forward after the brandmaker lost a pair of appeals in patent infringement lawsuits seeking to block ANDAs against the product. Read More
Taiwan-based TWi Pharmaceuticals has won final FDA approval for a generic version of Par Pharmaceutical’s AIDS drug Megace ES, but the product’s launch remains on hold as the brandmaker appeals its 2011 patent infringement lawsuit. Read More
Israeli firm Teva has launched the first generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude in both its 0.5 mg and 1 mg tablet strengths. Read More
Teva is clear to market its version of AstraZeneca’s chronic obstructive pulmonary disorder drug Symbicort in the United Kingdom, after the High Court there struck down an AZ indication patent on grounds of obviousness. Read More