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BB: ABRX, siehe link Able Laboratories Receives Approvable Letter from FDA For Tramadol Hydrochloride Tablets, 50mg PR Newswire, Wednesday, January 23, 2002 at 08:08 /FROM PR NEWSWIRE 800-682-9599/ [STK] ABRX [IN] BIO MTC OTC [SU] OTC TO BUSINESS AND MEDICAL EDITORS: Able Laboratories Receives Approvable Letter from FDA For Tramadol Hydrochloride Tablets, 50mg - Generic version of Ultram (R) with Estimated Total Market of $550 million - SOUTH PLAINFIELD, N.J., Jan. 23 /PRNewswire/ -- Able Laboratories, Inc. (BB:ABRX), today announced it has received notification from the United States Food and Drug Administration (FDA) that the Company`s Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Tablets, 50mg is approvable. The notification followed the FDA`s Division of Bioequivalence determination that Able`s Tramadol Hydrochloride Tablets 50mg are bioequivalent and, therefore, therapeutically equivalent to the Ultram(R) Tablets of R.W. Johnson Pharmaceutical Research Institute. Final approval is subject to the FDA`s resolution regarding approved labeling for the reference-listed drug and related pediatric exclusivity. The total brand market for Ultram(R), an analgesic tablet for the treatment of persistent moderate to severe pain, is estimated to be $550 million by IMS Data. Able Laboratories (BB:ABRX) is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 12 ANDA approvals and one New Drug Approval. The Company has recently completed its transition to focus its 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., contain 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, current or expected market size for the products, the success of current or future product offerings, research and development efforts and the Company`s ability to file for and obtain US Food and Drug Administration approvals for future products. There is no assurance that the Company will achieve the sales levels that will make its operations profitable or that ANDA filings and approvals will be completed and obtained 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 directly, indirectly or implied 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 September 30, 2001. Ultram is a registered trademark of R.W. Johnson Pharmaceutical Research Institute. MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X67488648 SOURCE Able Laboratories, Inc. -0- 01/23/2002 /CONTACT: Catherine M. Frost of Able Laboratories, +1-603-868-1357/ Companies or Securities discussed in this article: Symbol Name BB:ABRX Able Laboratories ## (BB) |
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| aus der Diskussion: | generics |
| Autor (Datum des Eintrages): | southbound (24.01.02 04:55:37) |
| Beitrag: | 59 von 125 (ID:5414037) |
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