Aurobindo Pharma gets USFDA nod to make, market asthma drug, stock up 2%

The nod for Budesonide inhalation suspension a day after the company got the US regulator’s nod to market a generic medication for the treatment of HIV-1 infection

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Aurobindo Pharma on November 30 said its wholly owned subsidiary had received the final nod from the US Food and Drug Administration (USFDA) to manufacture and market an asthma drug.

Eugia Pharma Specialities Limited will make and sell Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule. The drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pulmicort Respules (budesonide) inhalation suspension by Astrazeneca Pharmaceuticals.

The drug is expected to be launched in FY25. It had an estimated market size of $226.4 million for the twelve months ending September 2023, according to IQVIA, an analytical research agency.

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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, the company said.

At 1 pm, Aurobindo Pharma was trading 2 percent higher at Rs 1,039.65 on the BSE.

The approval comes a day after the company said it received a separate approval from the US health regulator to market a generic medication for the treatment of human immunodeficiency virus (HIV-1) infection.

The company received final approval to manufacture and market Darunavir tablets in strengths of 600 mg and 800 mg, the Hyderabad-based drug maker said in a regulatory filing.

Darunavir tablets, 600 mg and 800 mg, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older.

As per IQVIA data, the approved product has an estimated market size of USD 274.8 million for the 12 months ended October 2023.

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