Aurobindo unit gets USFDA nod to market generic asthma medication
Eugia Pharma Specialities 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.
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.
Shares of Aurobindo Pharma were trading 1.51 per cent up at 1,036.55 apiece on the BSE.
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