Aurobindo Pharma on November 30 said its subsidiary has received approval from the U.S. health regulator to market a generic medication to treat asthma in children.
Eugia Pharma Specialities, a wholly-owned subsidiary of the company, has received final approval from the U.S. Food & Drug Administration (USFDA) to manufacture and market Budesonide Inhalation Suspension, the Hyderabad-based drug firm said in a regulatory filing.
The company's product is therapeutically equivalent to AstraZeneca Pharmaceuticals LP's Pulmicort Repsules Inhalation Suspension, it added.
The product, indicated for treatment of asthma and as prophylactic therapy in children of age 12 months to 8 years, is expected to be launched in FY25, Aurobindo Pharma said.
As per IQVIA data, the approved product has an estimated market size of $226.4 million for the 12 months ended September 2023.
Shares of Aurobindo Pharma were trading 1.51% up at 1,036.55 apiece on the BSE.
