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The FDA has rejected Novartis’ heart drug Reasanz due to minimal data on efficacy, the latest regulatory setback for the experimental treatment. Read More
The FDA blasted generic drugmaker Alvogen for a promotion of the alcoholism treatment disulfiram that omitted potentially life-threatening risks. Read More
Abbott Labs is poised to double its presence in generic pharmaceuticals in Latin America with a planned purchase of Chile-based generics manufacturer CFR Pharmaceuticals, the companies announced Friday. Read More
Novartis has gained an extra seven months of marketing exclusivity on its blockbuster leukemia drug Gleevec in a settlement with Sun Pharma that permits the Indian manufacturer to launch a generic version of the drug in the U.S. as early as Feb. 1, 2016, the firms said yesterday. Read More
The FDA’s proposal to give generic manufacturers the same labelling authority as brand manufacturers is nothing short of “illegal,” argue two prominent FDA observers. Read More
European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official told DID. Read More
Teva’s zero-hour attempt to prevent generic competition to its blockbuster multiple sclerosis drug Copaxone was halted Wednesday when a federal judge threw out its lawsuit calling for ANDA applicants to meet additional requirements. Read More
Beleaguered Indian generics maker Wockhardt is recalling 109,744 bottles of the hypertension drug metoprolol due to problems with how the product dissolves in the body. Read More