Indian drugmaker Lupin has received U.S. FDA approval for its Cefdinir suspension 125 mg/5 ml. Cefdinir is a third-generation cephalosporin administered orally to treat a wide variety of bacterial infections. It is the generic version of U.S.-based Abbott's Omnicef.
"The approval of our Cefdinir suspension and the recent approval for the capsule form by the FDA reinforces Lupin's ability to submit high-quality dossiers and gain approvals in time," said Kamal Sharma, managing director at Lupin.
Lupin is the first company to receive abbreviated new drug application (ANDA) approval for both capsule and suspension forms of Cefdinir, said the company.