Alembic Pharma Secures USFDA Approval For Generic Injection

Alembic Pharmaceuticals Ltd announced that the US health agency has granted final approval for its generic Icatibant injectable, which is recommended for the treatment of acute bouts of hereditary angioedema in adults. Alembic Pharmaceuticals said in a regulatory filing that the US Food and Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) for Icatibant injection in strengths of 30 mg/3 mL (10 mg/mL) single-dose prefilled syringes.

The pharma firm stated that this is the company's first USFDA approval for a peptide product. The approved ANDA is therapeutically similar to Takeda Pharmaceuticals USA, Inc's reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10 mg/mL), the company said.

Icatibant injection is used to treat acute bouts of hereditary angioedema (HAE) in persons 18 years and older. Hereditary angioedema is a condition marked by recurrent episodes of extreme swelling (angioedema) in various body areas. According to the business, the injection has an expected market size of USD 112 million for the 12 months ending March 2024, based on IQVIA data.

Alembic Pharmaceuticals Ltd. is an Indian multinational pharmaceutical firm based in Vadodara. It manufactures pharmaceutical goods, chemicals, and intermediates. It is also referred to as the market leader in the macrolides segment of anti-infective medications in India.