Zydus gets USFDA nod to market asthma-treating Theophylline extended-release tablets

AHMEDABAD — Indian drug major Zydus Lifesciences on Wednesday received final approval from the US Food and Drug Administration (USFDA) to market Theophylline Extended-Release tablets to treat asthma.

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.

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.