Breckenridge Announces Approval for Repaglinide Tablets, USP
BOCA RATON, Fla., April 29, 2015 /PRNewswire/ — Breckenridge Pharmaceutical, Inc. announces the final approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Repaglinide Tablets USP, which is being manufactured and supplied by Standard Chem. & Pharm. Co., Ltd. Taiwan, and will be available in 0.5mg, 1mg, and 2mg strengths. Repaglinide Tablets are AB rated to Prandin®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The product launch plans are being finalized and first shipment will occur shortly.
Breckenridge Pharmaceutical, Inc. is a privately-held pharmaceutical marketing, research and development company founded in 1983 that 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, soft gel capsules, liquids, suspensions, and powders. www.bpirx.com
About Standard Chem. & Pharm. Co., Ltd.:
Standard Chem. & Pharm. Co., Ltd. is a privately-held developer and manufacturer of finished dosage drug products and active pharmaceutical ingredients. Standard was founded in 1967 and has GMP/PICS certified manufacturing facilities located in Sinying, Taiwan. Standard is the leading pharmaceutical company of Taiwan, serving customers worldwide. www.standard.com.tw
*Prandin®, a registered trademark of Novo Nordisk A/S.
Source: PR Newswire Health