Breckenridge Announces Final Approval of its ANDA for Asenapine Sublingual Tablets, 2.5 and 10mg Strengths (generic for Saphris®)

[ December 11, 2020 ]

Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Asenapine Sublingual Tablets in 2.5mg and 10mg strengths (generic for Saphris®).  Breckenridge plans to launch these strengths immediately.  Additionally, the U.S. Food and Drug Administration granted tentative approval for the 5mg strength. This product was developed in collaboration with MSN Laboratories Private Limited. According to industry sales data, Saphris® generated annual sales of $239 million during the twelve months ending September 2020.

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 lives of the patients we and our customers serve.

About MSN:

MSN Group is the fastest growing research based pharmaceutical company headquartered in India. Founded in 2003 with a mission to make health care affordable, MSN has nine API and five finished dosage facilities in Hyderabad and the U.S. The Group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals. With its core focus on speed and consistency in delivery, MSN has achieved more than 650 national and international patents, is world no. 1 in active U.S. DMF filings, has a product portfolio featuring over 380 APIs and over 250 formulations covering over 35 major therapies and has won the trust of more than 40,000,000 customers across 65 countries worldwide.