Breckenridge Announces Approval of its ANDA for Miglustat Capsules (generic for Zavesca®)

BERLIN, Conn., April 21, 2022 /PRNewswire/ — Breckenridge Pharmaceutical, Inc. announces today that the US 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 USES-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 March 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 US 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 Pharmaceuticals, Inc.
Robert GasparinAssociate Vice President – ​​Business Development
Phone: 860-828-8140
E-mail: [email protected]

*All brand names and trademarks are the property of their respective owners.

SOURCE Breckenridge Pharmaceutical, Inc.


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