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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
A federal judge has tossed out all claims in a consolidated class-action antitrust lawsuit alleging that brandmaker Warner Chilcott executed a “reverse payment” to generics firms Watson (now Actavis) and Lupin Pharmaceuticals to delay generic competition on its contraceptive Loestrin 24. Read More
Sandoz must wait until a patent on United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin expires in 2017 before it can market a generic version. Read More
The FDA has warned four generic drug manufacturing facilities that they haven’t paid their GDUFA fees for the last two fiscal years, meaning all of their products are automatically misbranded. Read More
Teva and AstraZeneca want a consolidated class action lawsuit alleging they conspired to delay generic entry of AstraZeneca’s acid-reflux drug Nexium dismissed, arguing that Teva couldn’t have marketed its version sooner due to approval delays plaguing Ranbaxy, which has first-to-file exclusivity. Read More