Able Laboratories Receives FDA Approval for Promethazine Hydrochloride Suppositories, USP 50mg; First AB-Rated Generic Version of Wyeth-Ayerst Phenergan 50mg Suppository.Business Editors/Health/Medical Writers SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--Feb. 28, 2003 Able Laboratories, Inc. (Nasdaq:ABRX) (BSE See Bombay Stock Exchange. BSE See Boston Stock Exchange (BSE). :AAB), today announced that 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 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) for Promethazine Hydrochloride Suppositories suppositories, n.pl solid capsules made of materials that melt at body temperature and are used to deliver medicinal substances into the rectum. , USP USP - unique sales point 50mg. This product is equivalent to Phenergan(R) Suppositories, USP 50mg of Wyeth-Ayerst Laboratories. The total market for Able's newly approved drug (used in the treatment of allergies, anaphylactic reaction, pre/post-operative sedation, nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. ) is estimated to be approximately $7 million according to recent IMS data. This represents the first generic AB-rated Promethazine Hydrochloride Suppository suppository /sup·pos·i·to·ry/ (su-poz´i-tor?e) an easily fusible medicated mass to be introduced into a body orifice, as the rectum, urethra, or vagina. sup·pos·i·to·ry n. , USP 50mg available to the market. Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 24 ANDA approvals. Further information on Able may be found on the Company's web site, www.ablelabs.com. Except for historical facts, the statements in this news release, as well as oral statements or other written statements made or to be made by Able Laboratories, Inc., 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 and involve risks and uncertainties. For example, statements about the Company's operations, capital-raising transactions and financial accounting, the current or expected market size for its products, the success of current or future product offerings, the research and development efforts and the Company's ability to file for and obtain U.S. Food and Drug Administration approvals for future products, are forward-looking statements. Forward-looking statements are merely the Company's current predictions of future events. The statements are inherently uncertain, and actual results could differ materially from the statements made herein. 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. For a description of additional risks, and uncertainties, please refer to the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2001 and its Form 10-Q for the nine months ended September 30, 2002. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments. |
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