Zydus Lifesciences Ltd announced on Wednesday that it has received final approval from the US Food and Drug Administration (USFDA) to market its generic Theophylline extended-release tablets. These tablets are used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).
The approval covers Theophylline extended-release tablets in strengths of 300 mg and 450 mg, according to the regulatory filing by Zydus Lifesciences. Theophylline is a bronchodilator that helps relax muscles in the lungs and decreases the lungs’ response to irritants, making it easier to breathe for individuals suffering from asthma and COPD.
The drug will be manufactured at Zydus Lifesciences’ formulation manufacturing facility located in the Ahmedabad Special Economic Zone (SEZ) in India.
Theophylline extended-release tablets in the 300 mg and 450 mg strengths had annual sales of USD 12.6 million in the US, according to IQVIA MAT data from March 2024, Zydus Lifesciences reported. This approval marks a significant step for Zydus Lifesciences in expanding its portfolio of respiratory care medications in the US market, further solidifying its presence in the global pharmaceutical industry.
