Pharmaceutical Business review

Sun Pharma Obtains FDA’s Tentative Approval For Generic Strattera Capsules

Sun Pharma has received tentative approval from the FDA for an Abbreviated New Drug Application (ANDA) for generic Strattera, atomoxetine hydrochloride capsules.

The company said that these atomoxetine hydrochloride capsules, therapeutically equivalent to Strattera capsules from Eli Lilly, are available in seven strengths such as 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg.

Strattera is part of a total treatment program to help manage the symptoms of ADHD, claims the company. The Strattera capsules are indicated for the treatment of attention deficit hyperactivity disorder. It is a registered trademark of Eli Lilly and Company (Eli Lilly).

Strattera affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Sun Pharmaceutical is an international, integrated, speciality pharmaceutical company. It manufactures and markets a portfolio of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the globe.