Business Editors/Health & Medical Writers
SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--July 25, 2001
Generic Version of Esgic Plus(R) With Estimated
Generic Market of $16 Million
Able Laboratories, Inc. (OTCBB:ABRX), today announced it has received Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophene, Caffeine Tablets USP, 50mg/500mg/40mg. The approval followed the FDA's Division of Bioequivalence's determination that Able's Butalbital, Acetaminophene, Caffeine Tablets USP, 50mg/500mg/40mg are bioequivalent and, therefore, therapeutically equivalent to the Esgic Plus(R) tablets of Mikart, Inc. The generic market for Able's newly approved drug, an analgesic tablet used as a pain reliever and relaxant for the treatment of tension and muscle contraction headaches, is estimated to be $16 million by IMS Data.
"These are very exciting times for us. Yesterday, we announced we had received FDA approval for our generic equivalent of Fioricet(R)," commented Jay Wadekar, President and Chief Operating Officer of Able Laboratories, Inc. "I am extremely pleased to announce this second approval today. We have now received four FDA approval in July alone with a total of nine since November 2000. Additionally, we currently have six ANDAs pending approval and our R&D efforts are continuing to feed our new product pipeline."
"I would like to congratulate our employees for all their hard work and the resulting nine FDA approvals we have received in less than eight months," stated C. Robert Cusick, Chairman and Chief Executive Officer of Able Laboratories, Inc. "It is our strategy to focus our continuing R&D efforts on areas of the generic market where we believe we can utilize our expertise and skill. These areas include suppositories and extended release formulations. We also are searching out niche areas with little competition or that will add breadth to our rapidly growing product line."
Able Laboratories (OTCBB:ABRX) is a rapidly growing developer and manufacturer of generic pharmaceuticals. Able's focus is to develop products that offer attractive market opportunities within selected niche markets of the generic drug industry. Able has recently completed its transition to focus the company's activities primarily on generic drug development, manufacturing and sales.
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking Statements. Certain information included in this news release (as well as information included in oral statements or other written statements made or to be made by Able Laboratories, Inc. f/k/a DynaGen, Inc.) contain statements that are forward-looking, such statements relate to anticipated future revenues of the company success of current product offerings, research and development efforts and the timeliness of Food and Drug Administration (FDA) filings and approvals. There is no assurance that the company will achieve the sales levels that will make the operation profitable or that FDA filings and approvals will be completed as anticipated. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future and accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Able Laboratories, Inc. f/k/a DynaGen, Inc. For a description of additional risks, and uncertainties, please refer to Able Laboratories, Inc. f/k/a DynaGen, Inc. filings with the Securities and Exchange Commission, including Forms 10 -KSB and 10-Q.
Esgic Plus is a registered trademark of Mikart, Inc.
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