Zydus Lifesciences Gets USFDA Nod for Asthma Drug
Zydus Lifesciences receives USFDA approval for its generic Theophylline extended-release tablets for treating asthma and COPD. The drug will be manufactured in Ahmedabad.
Photograph: Courtesy Zydus.
New Delhi, May 22 (PTI) 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.
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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