USFDA approves Alembic Pharma's generic Icatibant injection

18 Jun 2024 , 02:45 PM

Alembic Pharmaceuticals Ltd announced receiving final approval from the USFDA for its generic Icatibant injection. The injection is used to treat acute attacks of hereditary angioedema (HAE) in adults and is available in strengths of 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe. This marks Alembic’s first peptide product approval from the USFDA.

At the time of writing, on June 18, 2024 at 2:43 pm shares of Alembic Pharmaceuticals Ltd are trading at ₹869 which is a 2.16% dip than the previous close.

The approved ANDA is considered therapeutically equivalent to Firazyr Injection (30 mg/3 mL) by Takeda Pharmaceuticals USA, Inc. HAE is characterized by recurrent severe swelling of various body parts. According to IQVIA data, the market size for Icatibant injection was approximately $112 million for the 12 months ending March 2024.

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