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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.
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