Zydus Lifesciences Gets USFDA Nod for Generic Asthma Drug

Zydus Lifesciences Ltd received final approval from the USFDA to market its generic Theophylline extended-release tablets for treating asthma and COPD. The approval covers 300 mg and 450 mg strengths. The drug, to be manufactured in Ahmedabad SEZ, had annual US sales of USD 12.6 million.

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.

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