DynaGen Receives FDA Approval for Methylphenidate Extended Release 20 mg Tablets; Generic Version of Ritalin Extended Release With Estimated Market of $100 Million.Business Editors/Health & Medical Writers SOUTH PLAINFIELD, N.J.--(BW HealthWire)--May 10, 2001 DYNAGEN, INC. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :DYGN) (BSE See Bombay Stock Exchange. BSE See Boston Stock Exchange (BSE). :DYGN) today announced its wholly-owned subsidiary, Able Laboratories, Inc. 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 Methylphenidate methylphenidate /meth·yl·phen·i·date/ (meth?il-fen´i-dat) a central stimulant, used in the form of the hydrochloride salt in the treatment of attention-deficit in children and narcolepsy. Extended Release 20 mg tablets. The approval followed the FDA's Division of Bioequivalence's determination that Able's Methylphenidate Hydrochloride Extended Release Tablets USP USP - unique sales point , 20 mg, are bioequivalent and, therefore, therapeutically equivalent to the Ritalin-SR(R) 20 mg Tablets of Novartis Pharmaceutical Corporation. 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 estimates the generic market for DynaGen's newly approved drug to be $100 million. "Receiving approval on a sustained release formulation is a big achievement for us," stated C. Robert Cusick, Chairman and Chief Executive Officer of DynaGen, Inc. "This is the third ANDA approval we have received in the past six months. Our investments in our manufacturing facilities and Research and Development are coming to fruition. We now have twelve ANDA filings pending with the FDA. We anticipate receiving several of these approvals over the next three months and the rest before year-end." DynaGen filed its ANDA for Methylphenidate Extended Release 20 mg tablets in November 2000. Manufacturing of the product will begin immediately at Able Laboratories and the Company anticipates shipment of the product to commence shortly. 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 twelve products at various stages of FDA approval. The Company has recently completed its transition from a manufacturing and distribution company into a sole development and manufacturing entity. As part of the Company's commitment to its new strategic focus, the Company will change its name from DynaGen, Inc. to Able Laboratories, Inc. shortly. 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 DynaGen, Inc.) contain statements that are forward-looking, such statements relate to anticipated future revenues of the companies and success of current product offerings. There is no assurance that the company will receive FDA approvals for its new products or achieve the sales levels that will make the operation profitable. Such forward-looking information involves significant 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 DynaGen, Inc. For a description of additional risks, and uncertainties, please refer to DynaGen, Inc., filings with the Securities and Exchange Commission, including Forms 10-KSB and 10-QSB. Ritalin is a registered trademark of Novartis. |
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