Alembic Pharma Secures USFDA Nod for Icatibant Injection

Alembic Pharmaceuticals Ltd has received final approval from the US FDA for its generic Icatibant injection, used to treat acute hereditary angioedema in adults. This approval marks the company's first peptide product endorsement. The market size for this injection is estimated at USD 112 million for the fiscal year ending March 2024.


PTI | New Delhi | Updated: 17-06-2024 13:31 IST | Created: 17-06-2024 13:31 IST
Alembic Pharma Secures USFDA Nod for Icatibant Injection
AI Generated Representative Image
  • Country:
  • India

Alembic Pharmaceuticals Ltd celebrated a landmark achievement on Monday, securing final approval from the US Food and Drug Administration (USFDA) for its generic Icatibant injection, targeted for treating acute attacks of hereditary angioedema (HAE) in adults.

According to the company's regulatory filing, the approval pertains to the Abbreviated New Drug Application (ANDA) for the Icatibant injection, which comes in strengths of 30 mg/3 mL (10 mg/mL) in a single-dose prefilled syringe.

This milestone marks Alembic Pharma's first peptide product to gain USFDA approval. The approved ANDA is considered therapeutically equivalent to the reference drug Firazyr Injection by Takeda Pharmaceuticals USA, Inc. The market value for the injection is estimated to be around USD 112 million for the 12 months ending March 2024, based on IQVIA data.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)

Give Feedback