Launch represents first available generic equivalent of Alkeran(R)
LAKE FOREST, Ill., and NEWTOWN, Pa., June 9 /PRNewswire/ -- Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, and Synerx Pharma, LLC, announced today the FDA approval and launch of Melphalan Hydrochloride for Injection, the generic equivalent of Alkeran(R) from GlaxoSmithKline.
Bioniche Pharma and Synerx Pharma entered into a definitive agreement whereby Synerx developed and secured the U.S. Food and Drug Administration's approval of Melphalan and Bioniche Pharma has the exclusive rights to market and distribute Melphalan in the United States.
"The launch of Melphalan represents Bioniche's introduction to the generic injectable oncology market and underscores our commitment to rapid and aggressive product line growth," said George Zorich, President, US Operations for Bioniche Pharma. "We are pleased to have partnered with Synerx and value their expertise in developing this specialty generic product to meet the needs of cancer patients."
Bioniche Pharma will commence shipment of Melphalan Hydrochloride for Injection immediately in cartons with one single-use vial containing melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL vial of sterile diluent.
About Bioniche Pharma:
Bioniche Pharma is a global manufacturer of injectable pharmaceutical products serving a variety of niche markets, with expertise in injectable hyaluronic acid products for use in orthopedics, rheumatology, urology and dermatology. The company's growth is fueled by an internal development pipeline and an aggressive acquisition strategy for products. Bioniche Pharma was acquired in February 2006 by RoundTable Healthcare Partners, a private equity firm based in Lake Forest, Illinois. More information about Bioniche Pharma can be found at www.bionichepharma.com.
About Synerx Pharma:
Synerx Pharma, LLC is a privately help corporation located in historic Bucks County Pennsylvania. Established in January 2004, the company develops and brings to market select pharmaceutical products aimed at addressing unmet market needs, particularly those involving some combination of barriers to entry. The company focuses on developing cost effective specialty generic pharmaceuticals and small brand products. Synerx presently has five FDA approved products, and a development portfolio of ten projects at various stages of development in multiple dosage forms. More information can be found at www.synerxpharma.com
Alkeran(R) is a registered trademark of GlaxoSmithKline.
|SOURCE Bioniche Pharma|
Copyright©2009 PR Newswire.
All rights reserved