Able Laboratories Receives FDA Approval for Carisoprodol Tablets USP, 350 mg.; Generic Version of Soma Tablets with Estimated Generic Market of $260 Million.Business Editors/Health & Medical Writers SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--June 22, 2001 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 of 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 Carisoprodol Tablets USP USP - unique sales point 350 mg. The approval followed the FDA's Division of Bioequivalence's determination that Able's Carisoprodol Tablets USP, 350 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 Soma soma (sō`mə), psychotropic plant, the juice of which was sometimes drunk as part of the Vedic sacrifice (see Veda). Many hymns in the Rig-Veda are in praise of soma. (R) 350 mg Tablets of Wallace Laboratories. The generic market for Able's newly approved drug, mainly used as a muscle relaxant and for muscle spasms, is estimated to be $260 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 filed its ANDA for Carisoprodol Tablets USP, 350 mg. in October 2000. "This is the fourth FDA approval we have received in the last six months," stated C. Robert Cusick, Chairman and Chief Executive Officer of Able Laboratories, Inc. "These approvals and our other eleven pending FDA filings are the result of the Research and Development (R&D) investments we have made over the last two to three years. We have not stopped our R&D efforts. We will continue to have a consistent flow of new products over the quarters and years to come." Able Laboratories (OTCBB:ABRX), formerly DynaGen, Inc., is a rapidly growing developer and manufacturer of generic pharmaceuticals. The focus of the Company is to develop products that offer attractive market opportunities within selected niche markets of the generic drug industry. In addition to the eight products it is currently selling, the Company has eleven products in various stages of FDA approval. The Company has completed its transition that focuses 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 related to anticipated future revenues of the companies, success of current product offerings, research and development efforts and the timeliness of Federal 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. For a description of additional risks, and uncertainties, please refer to DynaGen, Inc. or Able Laboratories, Inc. filings with the Securities and Exchange Commission, including Forms 10-KSB and 10-Q. Soma is a registered trademark of WallaceLaboratories. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion