BALTIMORE, June 6 (UPI) -- Lupin said Tuesday it has been cleared to market a generic version of Abbott's Omnicef to treat bacterial infections.
The company, headquartered in Mumbai, India, said the Food and Drug Administration approved Cefdinir Powder for Oral Suspension, 125 mg/5 mL.
Lupin estimated U.S. sales of Abbott's Omnicef at approximately $137 million for the twelve months ending December 31, based on data from IMS Health. Those data also show that combined U.S. sales of Cefdinir capsules and suspensions were $634 million during the same time period.
The company got approval for a generic version of Omnicef in a capsule formulation in late May, noting it is the first to win marketing approval for generic Omnicef in both capsule and suspension formulations.
"Today's FDA approval of Cefdinir suspension and the recent approval of the capsule reinforces Lupin's ability on submitting high-quality dossiers and gaining approvals on time. This approval further strengthens our position in the Cephalosporin market in the U.S," said Lupin President and Managing Director Vinita Gupta.
