Able Laboratories Receives Three FDA Approvals; Market For Three Formulations of Phentermine Hydrochloride Estimated at Over $120 Million.Business Editors/Health & Medical Writers SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--Sept. 4, 2001 Able Laboratories, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :ABRX), today announced the Company has received three 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. ) approvals for its Abbreviated New Drug Applications (ANDAs) for Phentermine phentermine /phen·ter·mine/ (fen´ter-men) a sympathomimetic amine related to amphetamine, used as an anorectic either as the hydrochloride salt or as the base complexed with an ion exchange resin. Hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid. hy·dro·chlo·ride n. A compound resulting from the reaction of hydrochloric acid with an organic base. Tablets USP USP - unique sales point , 37.5mg; Phentermine Hydrochloride Capsules USP, 30mg; and Phentermine Hydrochloride Capsules USP, 30 mg (beads). The approval followed the FDA's Division of Bioequivalence's determination that Able's Phentermine Hydrochloride products 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 Adipex-P(R) tablets, 37.5 mg of Teva Pharmaceuticals USA, Inc., 30 mg capsules and 30 mg beaded capsules of Eon Labs Manufacturing, Inc. respectively. The total market for Able's newly approved drugs, sympathomimetic sympathomimetic /sym·pa·tho·mi·met·ic/ (-mi-met´ik) 1. mimicking the effects of impulses conveyed by adrenergic postganglionic fibers of the sympathetic nervous system. 2. an agent that produces such an effect. appetite suppressants used in the treatment of obesity, is estimated to be over $120 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. "We are extremely pleased with the addition of the Phentermine to our product line. Our R&D efforts over the last two years have produced eleven FDA approvals in the last four months," commented Jay Wadekar, President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of Able Laboratories, Inc. "We plan to continue to allocate resources to R&D and maintain a new product pipeline that we believe will allow us to remain competitive in the generic drug market." "We continue to expand our product line with niche items," stated C. Robert Cusick, Chairman and Chief Executive Officer of Able Laboratories, Inc. "Some of these products have been in short supply in the recent past which could prove beneficial in our market penetration efforts. Additionally, we currently have four ANDAs pending approval and we anticipate filing several more before the end of the year." 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. 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.) contains statements that are forward-looking statements within the meaning of 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. Forward-looking statements include statements about the Company's capitalization, anticipated growth and future operations, the success of current product offerings, research and development efforts and the Company's ability to file for obtain, and the Food and Drug Administration (FDA) filings and approvals for future products. There is no assurance that the Company will achieve the sales levels that will make its operations profitable or that FDA filings and approvals will be completed as anticipated. The Company's forward-looking statements involve important risks and uncertainties that could significantly affect anticipated results in the future and, accordingly, actual results may differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. For a description of additional risks, and uncertainties, please refer to the Company's filings with the Securities and Exchange Commission, including its registration statement on Form S-3, File No. 333-64734, its Annual Report on Form 10-KSB for the year ended December 31, 2000 and its quarterly report on Form 10-Q for the quarter ended June 30, 2001. Adipex-P(R) is a registered trademark of Teva Pharmaceutical USA, Inc. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion