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.
Home » Market News » Zydus Lifesciences Gets USFDA Nod for Asthma Drug
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
© 2024 Rediff.com India Limited. All rights reserved. Disclaimer - Terms of Service - Privacy Policy - Feedback