USFDA approval granted for Asthma Treatment Drug

The USFDA approval covers Theophylline extended-release tablets in two strengths: 300 mg and 450 mg.

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USFDA Drug product Approval
USFDA Approval

Last Updated on June 4, 2024 by The Health Master

USFDA approval

Indian pharmaceutical giant Zydus Lifesciences Ltd. has secured a significant win, receiving final USFDA approval from the US Food and Drug Administration (USFDA) to market its generic Theophylline extended-release tablets, an Asthma Treatment Drug.

This medication is used for treating asthma and chronic obstructive pulmonary disease (COPD), representing a major step forward for Zydus’ expansion into the lucrative US market.

Zydus Now Set to Supply Theophylline in the US

  • The USFDA approval covers Theophylline extended-release tablets in two strengths: 300 mg and 450 mg.
  • These tablets will be manufactured at Zydus’ formulation manufacturing facility located within the Ahmedabad SEZ in India.

Theophylline Market Holds Promise for Zydus

  • Citing IQVIA MAT March 2024 data, Zydus estimates the annual US market size for Theophylline extended-release tablets (300 mg and 450 mg) to be a promising USD 12.6 million.

This USFDA approval signifies a strategic win for Zydus Lifesciences, granting them access to a sizeable market for a well-established medication used in treating prevalent respiratory conditions.

The ability to manufacture the drug in India allows Zydus to potentially offer a cost-effective option for patients in the US, further increasing their market competitiveness.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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