Lupin receives FDA Approval of Cefdinir for Oral Suspension, 250 mg/5 mL

Lupin Ltd on May 08, 2007 has announced that the Company has received approval from the U.S. Food and Drug Administrative (FDA) for its Abbreviated New Drug Application for Cefdinir for Oral Suspension, 250 mg/5mL. The Company was the first Company to receive approval from the U.S. FDA for the capsule form and the lower strength suspension on May 19, 2006, and May 31, 2006, respectively.

The Company's Cefdinir capsules and suspensions are the AB-rated generic equivalent of Abbott Laboratories’ Omnicef® which had U.S. sales of approximately US $ 787 million for the 12-month period ended December 31, 2006, according to IMS Health. Cefdinir is indicated for the treatment of patients with mild to moderate infections caused by susceptible bacteria.

Commenting on the approval of the 250 mg/5 mL suspension, Dr. Kamal K, Sharma, Managing Director, of the Company, said, "We are pleased with the approval of the double strength suspension and look forward to offering the entire product line to our customers." Last week, Abbott and Astellas withdrew their motion for Preliminary Injunction to stop any potential launch by the Company. The Company has launched the complete range in the U.S. This is the 20th ANDA approval received by the Company.

Source : Equity Bulls

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