FDA accepts Fortesta response

Endo Pharmaceuticals Holdings Inc. (NASDAQ:ENDP) disclosed in its 2Q10 financial results that FDA accepted its response to last year's complete response letter for Fortesta 2% testosterone gel. The agency designated the response as a Class 2 resubmission and assigned a PDUFA date of Dec. 30. The NDA is under review to treat male hypogonadism.

Endo reported 2Q10 adjusted diluted EPS of $0.81, beating by $0.01 the Street's estimate of $0.80 and up 11% from $0.73 in 2Q09. Second quarter revenue for the company was $396.5 million, up 6% from $373.1 million in 2Q09 and above the Street's estimate of $391.9 million. Endo raised its full-year adjusted diluted EPS guidance to $3.25-$3.30 from $3.15-$3.20. The company reiterated its full-year revenue guidance of $1.63-$1.68 billion. ...