Zydus Cadila has received a tentative approval form the US FDA for its Abbreviated New Drug Application (ANDA) for Ribavirin tablets (200 mg). This anti-viral therapy falls in the anti-infectives segment and will go off patent this December.
The tentative approval for Ribavirin tablets is the latest in a series of development that mark Zydus Cadila’s foray in the US generic markets, claims a company release.
The company has received 7 ANDA approvals so far. The group recently launched Atenolol in the US market through its US subsidiary, Zydus Pharmaceuticals USA Inc. The current sales of Ribavirin tablets in the US market are estimated at 220 million USD according to NDC Health.
The process of filing ANDA’s began in 2003-04 with the group filing 12 ANDA’s, the largest number filed by an Indian company in the very first year of filing, added the release.