Breckenridge Pharmaceutical's ANDA for Miglustat Capsules, 100mg strength receives US FDA final approval
22 April 2022 -

Breckenridge Pharmaceutical, Inc, a US subsidiary of Japan-based Towa Pharmaceutical, announced on Thursday that the company has received final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Miglustat Capsules (generic for Zavesca), 100mg strength.

A United States-based manufacturer will commercialise the product.

The company is planning to launch the product during the third quarter of 2022 and it will be provided in a 90-count bottle.

According to industry sales data, Zavesca and its generics had annual sales of USD15m during the twelve months ending February 2022.