Lupin Ltd today said it has got the approval of US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Meloxicam tablets used in the treatment of osteoarthritis and rheumatoid arthritis.
The approval is for Meloxicam tablets of strengths of 7.5 mg and 15 mg , the company informed the Bombay Stock Exchange.
"The approval of our Meloxicam ANDA further reinforces Lupin's ability on submitting high quality dossiers and gaining approval in time. Our thorough execution has enabled us to launch the product immediately," Lupin Managing Director Kamal K Sharma said.
Meloxicam is a generic equivalent of Boehringer Ingelheim's non-steroidal anti-inflammatory drug (NSAID), Mobic. Its sales in the US were approximately 1.1 billion dollars for the 12-month period ended December 2005 according to IMS Health, it added.
This is the company's 14th ANDA approval from US FDA, it said.