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Aurobindo Pharma’s Generic Antifungal Injection Gains USFDA Nod

Written by : Nikita Saha

December 28, 2023

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The US health regulator approved to manufacture and commercialise the generic posaconazole injection of 300 mg/16.7 mL (18 mg/mL), a single-dose vial, which is used to prevent serious fungal infections.

In a significant development, Hyderabad’s Aurobindo Pharma via its wholly-owned arm Eugia Pharma Specialities Ltd has received final approval from the US Food & Drug Administration (USFDA) for its generic antifungal injection.

The US health regulator approved to manufacture and commercialise the generic posaconazole injection of 300 mg/16.7 mL (18 mg/mL), a single-dose vial, which is used to prevent serious fungal infections.

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 owing to certain conditions.

Reportedly, the product is expected to launch in the last week of December 2023. Further, the approved product had an estimated market size of $25.4 million till October 2023.

Moreover, it 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).

Founded in 1986, by P. V. Ramprasad Reddy and K. Nityananda Reddy. Aurobindo Pharma is a fully integrated pharmaceutical company that aims to establish a formidable market presence on a global scale by launching scientifically advanced products that meet unmet medical needs and deliver exceptional value to consumers worldwide.

While its subsidiary, Eugia Pharma Specialities Limited was incorporated in April 2013. Eugia seeks to deliver good health globally, expeditiously, and extend its therapies to unmet medical needs in specialised products such as General Injectables, Oncology, Ophthalmics, and Hormonal products.

In a similar development, Zydus’ methylene blue injection gained USFDA approval. The novel injection is an oxidation-reduction agent indicated for treating pediatric and adult patients with acquired methemoglobinemia.

Days back, Hyderabad-based Granules India secured USFDA approval for generic pantoprazole sodium tablets. Pantoprazole sodium delayed-release tablets are specifically designed for addressing erosive esophagitis linked to GERD, a condition characterised by the backward flow of stomach acid causing heartburn and potential oesophagal injury.

Additionally, the medicine is indicated for the maintenance of healing of erosive esophagitis and pathological hypersecretory conditions, including Zollinger-Ellison (ZE) syndrome.


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