Lupin Ltd received US FDA approval for its Cefdinir suspension 125mg/5mL. Cefdinir is a third generation cephalosporin administered orally to treat a wide variety of bacterial infections.
Cefdinir is being marketed by Abbott under the Omnicef brand name. As per IMS, the sales of the Omnicef suspension 125 mg/5mL were $137 million and the combined sales for capsules and suspensions were US$634 million (MAT Dec. 2005).
"The approval of our Cefdinir Suspension and the recent approval for the Capsule form by the US FDA reinforces Lupin's ability on submitting high quality dossiers and gaining approvals in time. This approval further strengthens our position in the Cephalosporins business in the US," said Dr Kamal Sharma, managing director, Lupin.
Lupin is the first company to receive ANDA approval for Cefdinir for both, capsule and suspension forms. With this approval, Lupin now has 12 ANDAs approved by the US FDA.