Lupin has already received FDA approvals for the capsule form and the lower strength suspension, and with this approval the company can launch the entire product range, Mumbai-based Lupin said. Commercial shipment in the US has already commenced.
Omnicef had US sales of approximately $787 million for the 12-month period ending December 31, 2006, according to IMS Health. Cefdinir is indicated for the treatment of patients with mild to moderate infections caused by susceptible bacteria.
Vinita Gupta, president and managing director of Lupin Pharmaceuticals, said: “We are extremely pleased with the approval of the double strength suspension and look forward to offering the entire product line to our customers.”