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Injectable sterile drug manufacturer Pharmaceutics International received a Form 483 for its failure to adequately investigate particulates in products and conduct design inputs for its combination product. Read More
The FDA has approved Eli Lilly’s Cyramza in combination with paclitaxel for advanced stomach cancer after chemotherapy, following an approval this spring as a single therapy for treating the disease. Read More
The FDA has cleared Janssen and Medivir’s hepatitis C drug Olysio to be used in combination with Sovaldi, making it the latest drug to be paired up with Gilead Sciences’ blockbuster product. Read More
A federal court decision this fall granting orphan drug marketing exclusivity to Depomed’s post-shingles pain drug Gralise will stand, after the FDA withdrew an appeal filed earlier this week. Read More
The FDA chided drugmaker Sciecure Pharma for distributing a sales aid that touted overblown superiority claims and disregarded risk information surrounding its insomnia treatment Doral. Read More
Manufacturers don’t appear to be waiting for FDA guidance to meet a Jan. 1 deadline of the new track-and-trace law, and instead have begun implementing an electronic version of a widely used tracking form to satisfy the law’s requirements. Read More
Citing quality problems at two of Ranbaxy’s Indian manufacturing facilities, the FDA has revoked its tentative approvals for two of the company’s ANDAs, one for a generic of AstraZeneca blockbuster Nexium and the other for Hoffman-LaRoche AIDS drug Valycte. Read More
Mylan said yesterday it has launched a generic version of Warner Chilcott’s oral contraceptive Loestrin 24 Fe in the U.S., following final FDA approval. Read More