Product news from 09/23 News Brief

Share this article:

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).

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Business Briefs

Email Newsletters


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.