Halsey Drug Co., Inc. Announces ANDA Approval
biz.yahoo.com
Tuesday June 1, 8:58 am Eastern Time
Company Press Release
ROCKFORD, Ill.--(BUSINESS WIRE)--June 1, 1999--Halsey Drug Co., Inc. (AMEX-HDG) today announced that approval has been received from the U.S. Food and Drug Administration for the Company's Abbreviated New Drug Application (''ANDA'') for Prednisolone Syrup, USP 15 mg per 5 ml, the generic equivalent of Prelone Syrup®, a registered trademark of Muro Pharmaceuticals, Inc.
Commenting on the approval, Michael Reicher, President & CEO, stated that ''the approval for Prednisolone Syrup expands the Company's liquid line of products and will substantially reduce the seasonality of our liquid line that was heretofore dominated by cold and cough medications. This product is indicated in the treatment of a variety of conditions ranging from asthma to oncology. Further, this approval demonstrates the Company's R&D capabilities as well as our commitment to our customers to provide an ever expanding line of quality products to meet their needs.''
As previously disclosed, the Company is currently a defendant in an action filed with the United States District Court, Eastern District of New York, relating to the Company's Prednisolone Syrup. The complaint alleges the existence of a Joint Venture Agreement between the Plaintiff and the Company concerning the product and alleges that the Company has breached the Agreement. The complaint seeks monetary damages of approximately $20 million. The Company is vigorously defending this action and believes it has meritorious defenses to each of the allegations. This matter is currently in discovery.
Halsey Drug Company, Inc. together with its subsidiaries, is a manufacturer of generic drugs in solid and liquid dosage forms sold to distributors, wholesalers, drug store chains, institutions, government agencies and other pharmaceutical manufacturers nationwide, as well as a manufacturer of active pharmaceutical ingredients.
The statements in this press release are forward looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward looking statements involve risk and uncertainties which may affect Halsey's business prospects, including economic, competitive, governmental, technological, and other factors discussed in filings with the Securities and Exchange Commission.
This and past press releases for Halsey Drug Co., Inc. are available at Halsey's web site at www.halseydrug.com.
Contact:
Halsey Drug Co. Inc., Rockford
Peter A. Clemens, 815/399-2060
Vice President and Chief Financial Officer
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