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Actavis must remove its generic version of Endo’s noncrush-resistant painkiller Opana from the U.S. market by Oct. 13, a New York federal judge ruled Friday, citing infringement of Opana’s patents. Read More
Spectrum Pharmaceuticals is on track to file an NDA for its cancer drug apaziquone by the end of this year, following agreement with the FDA on a special protocol assessment for a Phase 3 clinical trial in patients with non-muscle invasive bladder cancer. Read More
Vaccines makers should submit individual case safety reports and attachments to the Vaccine Adverse Event Reporting System using either the direct database-to-database method or the eSubmitter tool method, the FDA says. Read More
The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says. Read More
Teva is voluntarily recalling 19,504 bottles of amphetamine tablets that could contain impurities, the latest in a series of recalls by the company this year. Read More