Drugmaker Zydus Cadila on May 13 announced it had received final approval from the FDA to market chlorthalidone tablets, the generic equivalent of Pfizer’s now-discontinued hypertension drug Thalitone.
Zydus Cadila, based in Ahmedabad, India, said in a statement it would produce chlorthalidone at its formulations manufacturing facility in the same city. The FDA cleared the company to manufacture 25 mg and 50 mg tablets.
Chlorthalidone is used to treat high blood pressure and hypertension, either alone or in combination with other drugs. It’s also been useful in treating edema in people with congestive heart failure, cirrhosis of the liver or kidney disorders. Pharmaceutical giant Pfizer previously manufactured 15 mg chlorthalidone tablets under the brand name Thalitone, but Thalitone was later pulled from the market.
The FDA determined Pfizer’s drug wasn’t withdrawn from sale for reasons of safety or efficacy after Clinipace Worldwide submitted a citizen petition in 2015 requesting the agency look into the reasons Thalitone was discontinued.
With the go-ahead on their chlorthalidone formula, Zydus Cadila said it now has 266 federal approvals under its belt, as well as 350 abbreviated new drug applications since it started filing.