Breckenridge Announces Final Approval of its ANDA for Clobazam Tablets (Generic for Onfi®)

BOCA RATON, Fla., Oct. 23, 2018 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Clobazam Tablets, CIV, generic for Onfi® Tablets by Lundbeck.  Breckenridge's Clobazam product was developed by its vertically integrated manufacturing partner and will be available in 10mg and 20mg tablets. The company plans to launch immediately.

Clobazam Tablets are a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.   The brand Onfi® generated annual sales of $594 million dollars over the twelve months ending August 31, 2018, according to industry sales data.

About Breckenridge:
Breckenridge Pharmaceutical, Inc. is a privately-held own-label distributor that performs pharmaceutical marketing, research and development, as well as marketing and distribution in the U.S. The company was founded in 1983 and markets a broad range of generic prescription products in many therapeutic categories. The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide. The company markets over 70 products in a variety of dosage forms including: tablets, capsules, liquids, suspensions, ophthalmics, nasal sprays, powders and injectable products.
www.bpirx.com

Onfi® is a registered trademark of Lundbeck

SOURCE Breckenridge Pharmaceutical, Inc.