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Cardinal Health Inc. said it has received approval from the U.S. Food and Drug Administration to begin drug production at a plant in Raleigh, N.C., and will be adding more than 100 jobs at the facility.
United Research Laboratories, Inc. and Mutual Pharmaceutical Company, Inc. announce that Adams Respiratory Therapeutics has requested that Mutual agree to produce thousands of irrelevant documents related to the company's filing of an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) for Mutual's guaifenesin extended-release tablets, 600 mg and 1200 mg, which are the generic equivalent to Adams' Mucinex brand.
Mylan Laboratories Inc. announced that the U.S. Court of Appeals for the Federal Circuit upheld a district court decision that Mylan's Oxybutynin products do not infringe a patent for DITROPAN XL and that the patent was invalid.
A federal judge has rejected a request by Procter & Gamble Co. to force two other drug makers to stop marketing their osteoporosis medication because of alleged false claims.
Barr Pharmaceuticals, Inc. announced that its European subsidiary has filed an amended tender offer with the Croatian Financial Services Supervisory Agency to purchase 100% of the shares of PLIVA d.d., based in Zagreb, Croatia.
The FDA published its annual guidance document agenda and is seeking public comments on possible topics for future guidance development and revisions to existing documents.
Authors of a new report say it exonerates Merck from allegations that the company knowingly kept its painkiller Vioxx on the market despite underlying cardiovascular risks, but investigators also condemn Merck's "poor judgment and errors," including public statements that downplayed the health hazards.
Actavis U.S., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group, announced that it has begun shipping Pilocarpine Hydrochloride 7.5mg tablets to complement Pilocarpine 5mg tablets that the company currently offers.