Aurobindo Pharma’s wholly-owned subsidiary company, Eugia Pharma Specialities Ltd, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Budesonide Inhalation Suspension Single-Dose Ampule.
It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pulmicort Respules (budesonide) Inhalation Suspension by Astrazeneca Pharmaceuticals LP. The product is expected to be launched in FY25.
The approved product has an estimated market size of $226 million for the 12 months ending September 2023, the Hyderabad-based company said in a release. It is generally indicated to treat the symptoms of Asthma.
This is the 173rd ANDA approval (including nine tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oral and sterile specialty products.