Aurobindo Pharma Ltd shares gained more than 2% on Thursday after the company announced that its wholly-owned subsidiary Eugia Pharma Specialities Ltd received final approval from the United States Food & Drug Administration (USFDA) to manufacture and market Budesonide Inhalation suspension, 0.5 mg/2 mL Single-Dose Ampule.
Budesonide Inhalation Suspension is indicated for maintenance treatment of asthma and as a prophylactic therapy in children of age 12 months to 8 years.
The drug is bioequivalent and therapeutically equivalent to the reference listed drug PULMICORT RESPULES (budesonide) Inhalation Suspension by Astrazeneca Pharmaceuticals LP.
As per Aurobindio Pharma's stock exchange filing, the company expects to launch the product in the next financial year (FY25).
According to IQVIA data, the product has an estimated market size of $226.4 million for the 12 months to September 2023.
This is the 173rd ANDA approval (including nine tentative approvals) out of Eugia Pharma Specialities Group facilities, the company said.
Aurobindo Pharma on Wednesday announced receiving USFDA final approval to manufacture and market Darunavir Tablet, which is indicated for the treatment of HIV in adults.
It received approval for Darunavir Tablets in the 600mg and 800mg strength.
The drug is bioequivalent to the reference listed drug (RLD), Prezista Tablets, 600 mg and 800 mg, of Janssen Products, LP. The product will be launched on November 29, 2023.
Aurobindo Pharma shares were trading 2.05% higher at ₹1,042.40
apiece at 1pm.
(Edited by : Shloka Badkar)
First Published: Nov 30, 2023 1:13 PM IST
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