Ajanta Pharma Limited has received the final approval for Entacapone tablets from the US Food and Drug Administration (FDA). It is a bioequivalent generic version of Comtan tablets. The company will be launching the product shortly in 200 mg strength tablets.
The tablets are part of an ever growing portfolio of products that Ajanta has developed for the US market. In total, Ajanta has 35 Abbreviated New Drug Application (ANDA) of which it has final approvals for 20 ANDAs; tentative approvals for 2 ANDA; and 13 ANDAs are under review with US FDA.