Zydus Lifesciences Gets USFDA Nod for Asthma Medication
Zydus Lifesciences has received USFDA approval to market Theophylline extended-release tablets for asthma and COPD. The drug will be manufactured in Ahmedabad SEZ.
Photograph: Courtesy Zydus.
New Delhi, May 22 (PTI) Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to market a generic product to treat asthma.
The company has received final approval from the US Food and Drug Administration (USFDA) to market Theophylline extended-release tablets (300 mg and 450 mg), the drug firm said in a statement.
Theophylline is used to treat asthma and chronic obstructive pulmonary disease (COPD).
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, the drugmaker said.
As per the IQVIA MAT data, Theophylline extended-release tablets (300 mg and 450 mg) had annual sales of USD 12.6 million in the US.
The company has received final approval from the US Food and Drug Administration (USFDA) to market Theophylline extended-release tablets (300 mg and 450 mg), the drug firm said in a statement.
Theophylline is used to treat asthma and chronic obstructive pulmonary disease (COPD).
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, the drugmaker said.
As per the IQVIA MAT data, Theophylline extended-release tablets (300 mg and 450 mg) had annual sales of USD 12.6 million in the US.
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