Dr Reddy's on Thursday announced that the United States Food and Drug Administration (US FDA) has issued final approval for the Company's ANDA (abbreviated new drug application) for Ibuprofen 400, 600 and 800 mg tablets.
Ibuprofen is a non-steroidal anti-inflammatory drug indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. So many companies had already launched this product in US generics market as the patent for the product expired several years ago.
The combined annual sales value of Ibuprofen 400, 600 and 800 mg tablets in 2000 in the US market was approximately $ 73.6 million, according to a Dr Reddy's release.