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Several generic companies have come up short in their attempt to get into the Oxycontin and Risperdal market due to two court rulings announced Oct. 16.
Bayer suspended two people involved in a failure to disclose study results to the FDA that showed Trasylol could cause serious side effects, the company announced Oct. 13.
Health, Education, Labor and Pensions (HELP) Committee Chairman Sen. Mike Enzi (R-Wyo.) is readying to make another push for his drug safety bill when Congress returns after the November elections, a staffer on the majority HELP staff said.
The FDA approved Genentech's Avastin as a treatment against the most common kind of lung cancer, after clinical trials showed the drug could increase survival time.
CDER performed 45 Class I recalls of human drugs deemed to have "very serious potential to cause harm, injury or death" in the last fiscal year, according to Joe Famulare, acting deputy director of CDER's Office of Compliance.
Dr. Reddy's Laboratories will begin distributing an authorized generic version of GlaxoSmithKline's (GSK) migraine drug Imitrex in late 2008, under terms of a patent settlement.