Aurobindo Pharma arm gets USFDA nod for fungal infection drug

The drug maker on Friday announced that its wholly owned subsidiary, Eugia Pharma Specialties, has received a final approval from the US Food & Drug Administration (USFDA) for Amphotericin B Liposome for Injection.

Amphotericin B Liposome for Injection is indicated for empirical therapy for presumed fungal infection in febrile, neutropenic patients, treatment of Cryptococcal Meningitis in HIV-infected patients and treatment of visceral leishmaniasis.

Amphotericin B Liposome for Injection would be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), AmBisome Liposome for Injection, of Astellas Pharma US, Inc.

The pharmaceutical company said that the product is expected to be launched by Q4 FY23.

According to IQVIA, the approved product has an estimated market size of around $145 million for the twelve months ending September 2022.

This is a partnership product from TTY Biopharm Company and will be manufactured at their Taiwan facility and marketed by Eugia Pharma, the drug maker stated.

This is the 152nd ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.

The pharmaceutical company reported 41.3% fall in consolidated net profit to Rs 409.45 crore on a 3.7% decline in net sales to Rs 5,673.65 in Q2 FY23 over Q2 FY22.

Shares of Aurobindo Pharma were down 0.71% to Rs 470.75 on the BSE.

Powered by Capital Market - Live News