Zydus Lifesciences’ Asthma Treatment Approval


Zydus Lifesciences

Zydus Lifesciences, an Indian pharmaceutical company, obtained final approval from the US Food and Drug Administration (USFDA) to sell Theophylline Extended-Release tablets for asthma treatment (1 Trusted Source
Zydus Lifesciences

Go to source

).
Theophylline is used to treat asthma and chronic obstructive pulmonary disease (COPD).The company said that the US regulator approved the sale of the Theophylline tablets of dosages 300 mg and 450 mg.

Theophylline’s Journey to the US Market

The drug will be manufactured at the group’s formulation manufacturing facility in Gujarat’s Ahmedabad SEZ, it added.

According to March 24 IQVIA MAT (moving annual total) data, Theophylline Extended-Release tablets, 300 mg, and 450 mg had annual sales of $12.6 mn in the US.

The company further informed that it now has 396 approvals and has till March 31, filed over 460 Abbreviated New Drug Application (ANDAs) since the commencement of the filing process in FY 2003-04.

Reference:

  1. Zydus Lifesciences
    (https://www.zyduslife.com/zyduslife/)

Source-IANS





Source link