Breckenridge Announces Approval of its ANDA for Miglustat Capsules (generic for Zavesca®)
Berlin, Connecticut, April 21, 2022
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Miglustat Capsules (generic for Zavesca®), 100mg strength. The product will be will be commercialized from a USA-based manufacturer. Breckenridge plans to launch Miglustat Capsules during the third quarter of 2022 and the product will be offered in a 90-count bottle. According to industry sales data, Zavesca and its generics had annual sales of $15 million during the twelve months ending February 2022.
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