New Delhi, Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to market a generic product for the treatment of asthma.
The company has received final approval from the US Food and Drug Administration (USFDA) for the marketing of theophylline extended-release tablets (300 mg and 450 mg), the drug company said in a statement.
Theophylline is used to treat asthma and chronic obstructive pulmonary disease (COPD).
The drug maker said the drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ.
According to IQVIA MAT data, annual sales in the US for theophylline extended-release tablets (300 mg and 45 mg) were US$12.6 million.
The company has received final approval from the US Food and Drug Administration (USFDA) for the marketing of theophylline extended-release tablets (300 mg and 450 mg), the drug company said in a statement.
Theophylline is used to treat asthma and chronic obstructive pulmonary disease (COPD).
The drug maker said the drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ.
According to IQVIA MAT data, annual sales in the US for theophylline extended-release tablets (300 mg and 45 mg) were US$12.6 million.
