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 Approval Articles

Product news

July 10, 2007

Barr Pharmaceuticals said its subsidiary Barr Laboratories received FDA approval for its application to manufacture and market a generic version of Pharmacia and Upjohns Dostinex (cabergoline) tablets, 0.5 mg.
 

Novartis wins approval for Exelon patch

Stephen McGuire July 09, 2007

The FDA has approved a new patch form of Novartis Alzheimers disease treatment Exelon (rivastigmine transdermal system), the drugmaker said Monday.
 

Product news

July 03, 2007

Roche said the FDA has approved a supplemental New Drug Application to market Tamiflu (oseltamivir phosphate) capsules in 30 mg and 45 mg doses.
 

FDA approves generic versions of Lamisil

Stephen McGuire July 02, 2007

The FDA today approved the first generic versions of Novartis Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis).
 

Product news

June 19, 2007

Bradley Pharmaceuticals has announced the launch of Peranex HC Cream (hydrocortisone acetate 2% -- lidocaine HCl 2%) by the Companys Kenwood Therapeutics division.
 

Product news

June 05, 2007

Critical Therapeutics said the FDA has approved the companys New Drug Application (NDA) for twice-daily Zyflo CR (zileuton) extended-release tablets.
 

Wyeth&s Torisel enters crowded market

Marc Iskowitz June 01, 2007

The FDA approved Torisel (temsirolimus) from Wyeth for treating a type of advanced kidney cancer, but analysts say its potential may be limited.
 

Family Research Council file suit to overturn Plan B decision

James G. Dickinson June 01, 2007

The Family Research Council and a coalition of medical and women’s groups have filed suit to overturn the FDA’s decision to approve Plan B for OTC sales. They say the FDA lacked authority to approve the application and did so in response to political pressure.
 

Ten priority drugs approved in ’06

James G. Dickinson May 01, 2007

Ten priority drugs were approved in 2006, the FDA says, down five from 2005.