Breckenridge Announces Approval Of Its ANDA For Miglustat Capsules (generic For Zavesca®)

Berlin, CT /PRNewswire/ - 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.

About Breckenridge:
Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical (Osaka, Japan), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve.
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