Product news from 09/23 News Brief
AstraZeneca received FDA approval for Arimidex to be used as a breast cancer treatment following surgery or radiation. Arimidex was cleared for provisional accelerated approval in September 2002.
Merck announced that the FDA has approved its combination vaccine Proquad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) for simultaneous vaccination against measles, mumps, rubella (German measles) and varicella (chickenpox) in children 12 months to 12 years of age. Proquad is the first and only vaccine approved in the United States to help protect against these four diseases in a single shot.
The FDA has approved GlaxoSmithKline's influenza vaccine, Fluarix (influenza virus vaccine) for distribution for the 2005-2006 influenza season.
An FDA advisory panel has rejected Abbott's prostate drug Xinlay. While the panel's vote is nonbinding, FDA officials rarely overrule them. Abbott, though, is hopeful they will (see story, page 3).
Pfizer said it disagrees with the conclusions stated in a non-approvable letter it received from the FDA regarding parecoxib sodium, a non- narcotic injectable COX-2 selective analgesic for the treatment of acute pain. The company plans to meet with the FDA to discuss the agency's concerns (see story, page 3).