Lupin get USFDA approval for Cefdinir Suspension

Mumbai, Jun 2 (UNI) Lupin Ltd today announced that the US Food and Drug Administration (USFDA) has approved the company's Abbreviated New Drug Application (ANDA) for Cefdinir Suspension 125 mg/5 ml.

Cefdinir is a third generation cephalosporin administered orally to treat a wide variety of bacterial infections.

Cefdinir is being marketed by Abbott under the Omince brand name.

As per IMS, the sales of the Omnice Suspension 125 mg/5 ml were USD 137 million and the combined sales for capsules and suspensions were USD 634 million (MAT Dec 2005), the release said.

Lupin is the first company to receive ANDA approval for Cefdinir for both, Capsulte and Suspension forms. With this approval, Lupin now has 12 ANDAs approved by the USFDA.

In a release isued here Lupin Ltd's MD Kamal Sharma said, ''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 Cedphalosporins business in the US.'' UNI AR MJ AG1720