Zydus Lifesciences Limited, including its subsidiaries and affiliates (collectively referred to as "Zydus"), has obtained final approval from the United States Food and Drug Administration (USFDA) to market Theophylline Extended-Release Tablets in 300 mg and 450 mg dosages (USRLD: Theo-Dur Extended-Release Tablets).

Theophylline is prescribed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The approved medication will be manufactured at Zydus's formulation manufacturing facility in Ahmedabad SEZ, India.

Theophylline Extended-Release Tablets, in both 300 mg and 450 mg strengths, achieved annual sales of USD 12.6 million in the United States as of March 2024, according to IQVIA MAT data.

This approval marks Zydus's 396th approval, adding to the company's robust portfolio, with over 460 ANDAs filed since the initiation of the filing process in the fiscal year 2003-04.