Zydus Lifesciences secures USFDA approval for generic asthma drug

USFDA Approval: Zydus Lifesciences Ltd on Wednesday said that it has received final approval from the US health regulator to market its generic Theophylline extended-release tablets, commonly used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).

In a regulatory filing, Zydus Lifesciences said that the approval from the US Food and Drug Administration (USFDA) encompasses Theophylline extended-release tablets in strengths of 300 mg and 450 mg.

Manufacturing of the drug will take place at the company's manufacturing facility located in Ahmedabad SEZ.

According to data from IQVIA MAT March 2024, Theophylline extended-release tablets with strengths of 300 mg and 450 mg generated annual sales of $12.6 million in the US market, indicating significant market potential for Zydus Lifesciences' generic medication.

Following this development, Zydus Lifesciences shares ended 0.11 per cent lower at Rs 1,087.25.

(With PTI inputs)