Business Editors/Health & Medical Writers
SOUTH PLAINFIELD, N.J.--(BW HealthWire)--July 24, 2001
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/325mg/40mg. The approval followed the FDA's Division of Bioequivalence's determination that Able's Butalbital, Acetaminophene, Caffeine tablets USP, 50mg/325mg/40mg. tablets are bioequivalent and, therefore, therapeutically equivalent to the Fioricet(R) tablets of Novartis Pharmaceutical Corp. The total generic and brand market for Able's newly approved drug, a tablet used for the treatment of tension and muscle contraction headaches, is estimated to be $80 million by IMS Data.
"With today's announcement, we have now received eight FDA approvals since November 2000 and three approvals in July alone," commented Jay Wadekar, President and Chief Operating Officer of Able Laboratories, Inc. "We have now obtained ANDA approvals for generic versions of Ritalin SR(R), Ritalin(R), Lomotil(R), Soma(R), Darvocet-N(R) and Compazine(R) as well as one New Drug Application (NDA) approval. The total market for our recently approved products is estimated at over $1.2 billion by IMS Data. Additionally, we currently have seven ANDAs pending approval, several of which we anticipate before the end of the year."
"Our research and development strategies and focus are proving themselves as evidenced by our ability to file ANDAs, receive FDA approval and commence manufacturing and shipment of the product," stated C. Robert Cusick, Chairman and Chief Executive Officer of Able Laboratories, Inc. "We anticipate that these recent approvals will support revenue growth and bring us closer to profitability."
Able Laboratories (OTCBB:ABRX) is a rapidly growing developer and manufacturer of generic pharmaceuticals. 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.
Fioricet, Ritalin and Ritalin SR are registered trademarks of Novartis.
Compazine is a registered trademark of Smithkline Beecham Pharmaceuticals.
Darvocet-N is a registered trademark of Eli Lilly.
Lomotil is a registered trademark of G. D. Searle
Soma is a registered trademark of Wallace Laboratories
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