Ahmedabad: Zydus Cadila has received tentative approval from the US FDA for its abbreviated new drug application (ANDA) for Ribavirin tablets, 200mg. This anti-viral therapy falls in the anti-infectives segment and will go off patent in December 2005. The current sales of Ribavirin tablets (200 mg) in the US market as per NDC Health is estimated at $220 million USD.
The tentative approval for Ribavirin tablets is the latest in a series of developments that mark Zydus Cadila's entry in the US generic markets. So far the group has received seven ANDA approvals. The group recently launched Atenolol in the US market through its US subsidiary Zydus Pharmaceuticals USA Inc.
The process of filing ANDAs began in 2003-04 with the group filing 12 ANDAs, the largest number filed by an Indian company in the very first year of filing. Till date, the group has filed 27 ANDAs and 32 DMFs.