Zydus Lifesciences gets USFDA nod for asthma treatment drug

New Delhi: Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic Theophylline extended-release tablets used in the treatment of asthma and chronic obstructive pulmonary disease.

The approval by the US Food and Drug Administration (USFDA) is for Theophylline extended-release tablets of strengths 300 mg and 450 mg, Zydus Lifesciences said in a regulatory filing.

The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, India, it added.

Theophylline extended-release tablets, 300 mg and 450 mg had annual sales of USD 12.6 million in the US, Zydus Lifesciences said citing IQVIA MAT March 2024 data.