The US Food & Drug Administration (USFDA) has given Takeda Pharmaceuticals USA Inc's wholly owned subsidiary company, Eugia Pharma Specialities Limited, final approval to
produce and market Icatibant Injection, 30 mg/3 mL (10 mg/mL), Single-Dose Prefilled Syringe, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) FIRAZYR (Icatibant Injection), the company announced through an exchange filing.Launch of the product is scheduled for September 2023. According to IQVIA, the market size for the authorised product will be approximately US$ 137 million for the twelve months ending June 2023.This is the 166th ANDA (including 9 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.Adults 18 years of age and older can use icatibant injection to treat acute bouts of
hereditary angioedema (HAE).At 11:55 am IST today, Aurobindo Pharma shares were up 0.33 percent, trading at Rs 874.55.
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