Aurobindo Pharma receives three ANDA approvals from USFDA
Aurobindo Pharma has received the tentative approval for Atomoxetine Hydrochloride 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg and final approvals for Ribavirin tablets 200mg and Ribavirin Capsules 200mg from USFDA.
Atomoxetine Hydrochloride Capsules 10mg, 18mg, 25mg, 40mg, 60mg, 80 mg and 100mg are generic equivalent to Strattera of Eli Lily. However, Aurobindo Shares 180 days exclusivity with other generic companies subject to the final approval and launch based on the pending litigation with Eli Lilly.
The drug 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 USD 500 million for the twelve months ending March 2009.
Ribavirin Tablets 200mg is generic equivalent to Copegus Tablets of Hoffman La Roche Inc and Ribavirin Capsules 200mg is generic equivalent to Rebetol Capsules of Schering Corporation.
The drug is indicated in the treatment for the treatment of adults with chronic Hepatitis C Virus who have compensated liver disease and have not previously been treated with interferon alpha.
The product has a market size of approximately USD 90 million for the twelve months ending March 2009.