Lupin has received US FDA approval for its abbreviated new drug application (ANDA) for cefprozil oral suspension, 125 mg / 5 ml and 250 mg / 5 ml.
Cefprozil is the generic equivalent of Bristol Myers Squibb’s Cefzil. The suspension market in the US is USD 119 million as per IMS MAT June 2005 data. Earlier this month, Lupin received approval from the US FDA for Cefprozil tablets, informs a company release.
Dr. D B Gupta, chairman, Lupin said, "The timely approval of this ANDA now enables us to offer both the tablets and the powder for suspension which is essential for the product’s success. We look forward to capturing a profitable market share post patent expiry on December 23, 2005".
This is the company's tenth ANDA approval by the US FDA till date and the fifth in this financial year.