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

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.

On December 20, the pharma company released a statement about an inspection carried out by the US FDA at Unit IV, a formulation manufacturing facility owned by APL Healthcare Limited, a wholly-owned subsidiary of the company, located in Menakuru Village, Andhra Pradesh. The inspection took place from September 13 to September 19, 2023. Subsequently, the unit has received its Establishment Inspection Report, designating the facility as "Voluntary Action Indicated” (VAI).

In the last week of November, Eugia Pharma Specialities got approval by the US FDA for the production and distribution of Budesonide Inhalation Suspension. The approved drug serves as a treatment for asthma and is utilised as prophylactic therapy in children aged 12 months to 8 years.

The anticipated launch of Budesonide Inhalation Suspension in FY 2025 is projected to target a market size of $226.4 million for the twelve months concluding in September 2023, as per IQVIA estimates.

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