New Delhi: Ajanta Pharma has received final approval from the US health regulator for Entacapone tablets, used in the treatment of Parkinson’s disease.
In a BSE filing, Ajanta Pharma said it has received “final approval for Entacapone tablets from US FDA. It is a bioequivalent generic version of Comtan tablets”.
The company said it will launch the product shortly in the strength of 200mg tablets.
This new approval is part of the portfolio of products that the company has developed for the US market, it added.
Ajanta Pharma has 35 abbreviated new drug applications (ANDAs) of which it has final approval for 20 ANDAs, tentative approval for 2 ANDA and 13 ANDAs are under review with USFDA, Ajanta Pharma said.