Able Laboratories Receives Three FDA Approvals; Market For Three Formulations of Phentermine Hydrochloride Estimated at Over $120 Million
Business Wire
September 4, 2001
Able Laboratories, Inc. today announced the Company has received three Food and Drug Administration (FDA) approvals for its Abbreviated New Drug Applications (ANDAs) for Phentermine Hydrochloride Tablets USP, 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 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 appetite suppressants used in the treatment of obesity, is estimated to be over $120 million by IMS Data.
More News: Phentermine Drugmart.
"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 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 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.
Source: www.euromeds.co.uk |
