Business Editors/Health & Medical Writers
SOUTH PLAINFIELD, N.J.–(BUSINESS WIRE)–July 25, 2001
Generic Version of Esgic Plus(R) With Estimated
Universal Market associated with $16 Million
Capable Laboratories, Corporation. (OTCBB:ABRX), today announced it has obtained Food and Drug Administration (FDA) approval for its Shortened New Drug Application (ANDA) with regard to Butalbital, Acetaminophene, Caffeine Pills USP, 50mg/500mg/40mg. The approval adopted the FDA’s Department of Bioequivalence’s dedication that Able’s Butalbital, Acetaminophene, Coffee Tablets USP, 50mg/500mg/40mg are bioequivalent as well as, therefore, therapeutically equal to the Esgic In addition(R) tablets of Mikart, Inc. The universal market for Able’s newly approved drug, an pain killer tablet utilized as a pain reliever as well as relaxant for the treatment of tension as well as muscle contraction headaches, is estimated to be $16 million by IMS Data.
“These are extremely exciting times for us. The other day, we announced we had received FDA approval for our universal equivalent of Fioricet(R),” commented Jay Wadekar, Leader and Chief Operating Officer of Capable Laboratories, Corporation. “I am very pleased to announce this second approval these days. We have now received four FDA approval within July on your own with a complete of 9 since November 2000. Furthermore, we currently have six ANDAs impending approval as well as our R&D efforts are continuing to give our new product pipeline.”
“I would like to congratulate the employees for those their hard work and the resulting nine Food and drug administration approvals we have received in under eight months,” stated C. John Cusick, Chairman and Chief Executive Officer of Able Laboratories, Corporation. “It is the strategy to focus our continuing R&D efforts on areas of the generic marketplace where we believe we can utilize our expertise and skill. These areas include suppositories as well as extended release formulations. All of us also are searching out market areas with little competition or that will add width to our growing rapidly product line.”
Able Laboratories (OTCBB:ABRX) is a rapidly growing developer as well as manufacturer associated with generic pharmaceuticals. Able’s focus is to develop items that offer attractive market opportunities within chosen niche markets from the generic drug industry. Capable has recently finished its changeover to focus the business’s activities totally on generic drug development, production and sales.
The Private Securities Litigation Reform Behave of 1998 provides a “safe harbor” with regard to forward-looking Statements. Certain information one of them news launch (as well as information included in dental statements or other written statements made or to be made by Able Labs, Inc. f/k/a DynaGen, Inc.) contain claims that are forward-looking, such statements relate to anticipated future revenues from the company achievement of current product offerings, research as well as development efforts and the timeliness associated with Food and Drug Administration (FDA) filings as well as approvals. There is no assurance that the company will achieve the sales levels that will make the operation profitable or even that FDA filings and home loan approvals will be finished as anticipated. Such forward-looking information involves essential risks as well as uncertainties that could significantly impact anticipated leads to the future and accordingly, such results may differ materially from those expressed in any forward-looking statements produced by or on behalf of Able Labs, Inc. f/k/a DynaGen, Corporation. For a description of additional dangers, and uncertainties, please refer to Able Laboratories, Inc. f/k/a DynaGen, Inc. filings with the Investments and Trade Commission, including Forms 10 -KSB and 10-Q.
Esgic Plus is a registered trademark of Mikart, Inc.
