Aurobindo gets US FDA nod

Aurobindo Pharma Limited has received the tentative approval for Atomoxetine Hydrochloride capsules in 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, and 100mg strengths.

The company has also received final approvals for Ribavirin tablets 200mg and Ribavirin capsules 200 mg from the US Food and Drug Adminsitration.

Atomoxetine Hydrochloride capsules are generic equivalent to Strattera of Eli Lily and Company. Aurobindo shares 180 days exclusivity with other generic companies subject to the final approval and launch based on the pending litigation with Eli Lily, a company release said.

These tablets, which come under neurological segment, are used in treatment of attention deficiency and hyperactivity in children. The product had a market size of approximately $500 million (Rs 2,450 crore) for the 12 months ending March 2009.

Ribavirin tablets are generic equivalent to Copegus tablets of Hoffman La Roche Inc and Ribavirin capsules are generic equivalent to Rebetol capsules of Schering Corporation.

Ribavirin tablets and capsules are antiviral agents and are useful intreatment of chronic hepatitis C virus. The products had a market size of approximately $90 million (Rs 441 crore) for the 12 months ending March 2009 and will be launched shortly, the release added.