Able Laboratories Receives FDA Approval for Propoxyphene Napsylate and Acetaminophen 100 Mg and 650 Mg Tablets.Business Editors/Health & Medical Writers SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--July 12, 2001 Generic Version of Darvocet-N(R) With Estimated Generic Market of $450 Million Able Laboratories, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :ABRX), today announced it has received Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval for its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) for Propoxyphene Napsylate and Acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. Tablets USP USP - unique sales point 100 mg and 650 mg. The approval followed the FDA's Division of Bioequivalence's determination that Able's Propoxyphene Napsylate and Acetaminophen Tablets USP, 100 mg and 650 mg, are bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. and, therefore, therapeutically equivalent to the Darvocet-N(R) 100 mg and 650 mg Tablets of Eli Lilly. The generic market for Able's newly approved drug, an analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs combination used to relieve pain, is estimated to be $450 million by IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. Data. Able anticipates shipment of the product will commence immediately. "This is an important approval for us," stated C. Robert Cusick, Chairman and Chief Executive Officer of Able Laboratories, Inc. "The generic market for this drug is substantial and we believe we will be able to achieve quick market acceptance and, hence, market share. In addition to a New Drug Approval that we received last month, we have obtained 5 ANDA approvals in the last six months and we currently have ten ANDAs pending approval, several of which we anticipate very soon. Our R&D efforts have produced this ANDA pipeline and we look forward to introducing a steady flow of newly approved products in the coming quarters." 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. In addition to the one new drug application approval that the company recently received, it has obtained five ANDA approvals and has several ANDAs in various stages of FDA approval. Able has recently completed its transition to focus the company's activities solely on generic drug development, manufacturing and sales by divesting its distribution subsidiaries. The Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. Darvocet-N is a registered trademark of Eli Lilly |
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