Lupin gets US FDA approval for Meloxicam

20 Jul 2006

Mumbai: Lupin Ltd has announced that the US FDA has approved the company''s Abbreviated New Drug Application (ANDA) for Meloxicam tablets, 7.5mg and 15mg, a widely used non-steroidal anti-inflammatory drug (NSAID). Meloxicam is indicated for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.

The company''s Meloxicam Tablets are the AB-rated generic equivalent of Boehringer Ingelheim''s Mobic Tablets. U.S. sales for Mobic Tablets were approximately $1.1 billion for the 12-month period ended December 2005 according to IMS Health.

"The approval of our Meloxicam ANDA further reinforces Lupin''s ability on submitting high quality dossiers and gaining approval in time. In fact, the approval took just a little over nine months. In addition, our thorough execution has enabled us to launch the product immediately," said Dr. Kamal K. Sharma, Managing Director, of the Company.

The company is among the first cluster of companies to receive ANDA approval for Meloxicam. With this approval, the company now has 14 ANDAs approved by the US FDA.