Aurobindo Pharma receives USFDA approval for Atomoxetine Hydrochloride, Ribavirin

Aurobindo Pharma has received the tentative approval for Atomoxetine Hydrochloride Capsules 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg and final approvals for Ribavirin Tablets 200mg and Ribavirin Capsules 200mg from the US Food and Drug Administration (USFDA).

Atomoxetine Hydrochloride Capsules 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg are generic equivalent to Starttera 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg of Eli Lily and Company and contains Paragraph IV certification with first-to file status.

Aurobindo shares 180 days exclusivity with other generic companies subject to the final approval and launch based on the pending litigation with Eli Lily

Atomoxetine Hydrochloride Capsule is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 and older, teens and adults and falls under the neurological (CNS) segment. The product has a market size of approximately $500 million for the twelve months ending March 2009 according to Newport.

Ribavirin Tablets 200mg is generic equivalent to Copegus Tablets 200 mg of Hoffman La Rochce Inc and Ribavirin Capsules 200mg is generic equivalent to Rebetol Capsules 200 mg of Schering Corporation. Ribavirin Tablets and Capsules are antiviral agents indicated in the treatment of adults with chronic Hepatitis C Virus who have compensated liver disease and have not previously been treated with interferon alpha. The products have a market size of approximately $90 million for the twelve months ending March 2009 according to Newport and will be launched shortly.

Aurobindo now has total of 105 ANDA approvals (76 final approvals and 29 tentative approvals) from USFDA.