Watson Pharmaceuticals Inc announces FDA approval for generic Accuneb

Sep 27, 2007 (M2 EQUITYBITES via COMTEX) -- WPI | charts | news | PowerRating -- Watson Pharmaceuticals Inc (NYSE:WPI), aspeciality pharmaceutical company, reported on 26 September that the company has received final approval from the US Food and Drug Administration (FDA)for its Abbreviated New Drug Application (ANDA) for albuterol sulfate inhalation solution in the 0.021% (base) and 0.042% (base) strengths and plans to launch the product with immediate effect.

The company said it has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the 0.021% (base) strength. The market exclusivity will commence upon commercial launch of the product.

Albuterol sulfate is the generic equivalent to Dey L.P.'s AccuNeb Inhalation Solution, which is indicated for the relief of bronchospasm in patients two to 12 years of age with asthma (reversible obstructive airway disease). According to IMS Health data, AccuNeb had total US sales of approximately USD20m for the 12-months ending June 2007.

Comments on this story may be sent to admin@m2.com

Morning Coffee with TradingMarkets -- Free Newsletter

More News:   Market Updates | Stock Alerts | All Trading News | Stock Index