Aurobindo Pharma unit gets USFDA nod to market generic asthma medication

Aurobindo Pharma on Thursday said its subsidiary has received approval from the US 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 US 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 USD 226.4 million for the 12 months ended September 2023.

The company also received approval from the US Food and Drug Administration (USFDA) to manufacture and market Darunavir Tablets, 600 mg and 800 mg. The tablet is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Prezista Tablets, 600 mg and 800 mg, of Janssen Products, the company informed in a regulatory filing with the BSE on Wednesday, November 29.

The company said that the approved product could generate an estimated revenue of $274.8 million for the twelve months ending October 2023, according to IQVIA. As things stand, Aurobindo now has a total of 500 ANDA approvals from the USFDA. Among these, 478 are final approvals, and 22 are tentative approvals.

Shares of Aurobindo Pharma were trading 1.51 per cent up at 1,036.55 apiece on the BSE.