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 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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