The US Food and Drug Administration (US FDA) has approved Lupin's Abbreviated New Drug Application (ANDA) for Cefotaxime vials for injection 500 mg, 1g and 2g, the generic equivalent of Claforan marketed by Abbott Laboratories Inc.

This ANDA approval is the first injectable finished product approval for Lupin in the US market. Lupin is also the first Indian company to receive US FDA approval for an injectable finished product. This is also one of the few injectable plants approved outside the US and Europe.

At present, Lupin is supplying Cefotaxime API to its alliance partner APP for the US market. Lupin had filed its own ANDA to overcome any constraints that the alliance partner may have in future. APP launched the product in the US in the third quarter of 2001 as the first generic and continues to be the sole generic on the market. The market size of Cefotaxime is US $36.5 million (MAT June 2003) as per IMS.

Cefotaxime is a semi-synthetic, broad-spectrum cephalosporin antibiotic generally prescribed for infections of GI tract, lower respiratory tract infections, CNS (including ventriculitis and meningitis), surgical prophylaxis, gynecologic infections, intra-abdominal infections, septicemia and bacteremia.

This is the second ANDA approval for Lupin in this quarter. Lupin received FDA approval for Cefuroxime Axetil tablets in July 2003.

Lupin's revenue in FY 2002-03 was Rs.1,120 crore on an equity base of Rs. 40.1 crore. Nine of Lupin's plants have been approved by the US FDA and two plants have been approved by the UK MCA.