Shares of Aurobindo Pharma Ltd shares surged 1.6% to ₹1,067.65 after the company's arm received U.S. Food & Drug Administration (US FDA) final approval to produce and market posaconazole injection. The injection is specifically indicated for the prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised patients, including hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).

Eugia Pharma Specialities Ltd, a wholly-owned subsidiary of Aurobindo Pharma, has secured final approval from the US FDA for the production and marketing of posaconazole injection, 300 mg/16.7 mL (18 mg/mL), Single-Dose Vial. It is deemed bioequivalent to the reference listed drug (RLD), Noxafil Injection by Merck Sharp & Dohme LLC, the company stated in an exchange filing. It is anticipated to be launched in December 2023.

“Posaconazole Injection is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Noxafil Injection, 300 mg/16.7 mL (18 mg/mL), of Merck Sharp & Dohme LLC (Merck),” the company filing states.

The approved product is estimated to target a market size of $25.4 million for the 12 months concluding in October 2023, according to IQVIA, a U.S.-based clinical research services provider, as per the filing.

This is the173rd Abbreviated New Drug Application (ANDA) approval from Eugia Pharma Specialities Group's (EPSG) facilities, which are involved in the production of both oral and sterile specialty products.

“Posaconazole Injection, 300 mg/16.7 mL (18 mg/mL), Single-Dose Vial is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy,” the release notes.

Noxafil Injection

Aurobindo Pharma arm gets US FDA nod for posaconazole injection; share up 1.6%