Aurobindo Pharma shares touched an intraday high of ₹1,080.9 apiece, inching closer to their previous 52-week high on Wednesday after the company announced that its subsidiary had received the United States Food and Drug Administration (USFDA) approval for the Posaconazole Injection.
In a stock exchange filing, the pharma company said that its wholly-owned subsidiary Eugia Pharma Specialities Ltd received the USFDA approval for the manufacturing and marketing of Posaconazole Injection in the dose 300 mg/16.7 mL (18 mg/mL), in single-dose vials.
The Posaconazole Injection is used to prevent serious fungal infections, which can spread throughout the body in patients with low immunity.
This injection 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. For instance the patients undergoing a hematopoietic stem cell transplant (HSCT) with graft-versus host disease (GVHD), or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
The aforementioned drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Noxafil Injection, in the same dosage 300 mg/16.7 mL (18 mg/mL), provided by Merck Sharp & Dohme LLC (Merck), the company informed the bourses.
The Posaconazole injection is likely to be launched in December 2023, Aurobindo Pharma announced.
As per IQVIA MAT data for the 12 months ending October 2023, the Posaconazole Injection portrays an estimated market size worth USD 25.4 million in the United States.
Shares of Aurobindo Pharma were trading 1.26% higher at ₹1,077 per piece on BSE at 11:54AM.
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