Miglustat (Zavesca) Approved

[ April 21, 2022 ]

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.

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.

For further information, please contact:

Breckenridge Pharmaceutical, Inc.

Robert Gasparino, Associate Vice President – Business Development

Tel: 860-828-8140



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