October FDA Pipeline

October 1, 2004

FDA actions and new molecular entities

Cymbalta

Duloxetine

Lilly

New indications

Topamax

Topiramate

Ortho-McNeil

Epilepsy therapy approved for migraine prophylaxis

FDA Actions in brief FDA approved mixed salts of a single-entity amphetamine (Adderall XR, Shire Pharmaceuticals) as a once-daily treatment for attention deficit hyperactivity disorder (ADHD) in adults.

A liquid formulation of palivizumab (Synagis, MedImmune) was approved to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk for RSV disease.

FDA approved atorvastatin (Lipitor, Pfizer) for the prevention of cardiovascular disease by reducing heart attack risk in people with normal to mildly elevated levels of cholesterol but with other risk factors for heart disease.

Acamprosate (Campral, Lipha Pharmaceuticals) was approved for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.

FDA granted accelerated approval to pemetrexed (Alimta, Lilly) for the treatment of locally advanced or metastatic non-small-cell lung cancer in previously treated patients.