Able Laboratories Receives FDA Approval for Prochlorperazine Suppositories USP, 2.5 Mg, 5 Mg and 25 Mg.Business Editors/Health & Medical Writers SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--July 13, 2001 -- The Only Company to Offer Generic Version of Compazine(R) in All Three Strengths -- Able Laboratories, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :ABRX), today announced 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 Prochlorperazine prochlorperazine /pro·chlor·per·a·zine/ (pro?klor-per´ah-zen) a phenothiazine derivative, used as the base or the edisylate or maleate salts as an antiemetic and antipsychotic. pro·chlor·per·a·zine n. 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 , 2.5 mg, 5 mg and 25 mg. The approval followed the FDA's Division of Bioequivalence's determination that Able's Prochlorperazine suppositories USP, 2.5 mg, 5 mg and 25 mg, are bioequivalent and, therefore, therapeutically equivalent to the Compazine(R) suppositories 2.5 mg, 5 mg and 25 mg of Smithkline Beecham Pharmaceuticals. The generic market for Able's newly approved drug, a 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. used primarily to treat severe 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 $18 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. "Suppositories are challenging formulations and we are extremely pleased to have developed the technology and experience to formulate these types of dosage forms," 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. "One of our research and development strategies is to focus on specific areas that utilizes our technological expertise and will produce products that possess high margins. Our new approval fits perfectly in this niche." "We are extremely pleased to receive our second FDA approval in two days," stated C. Robert Cusick, Chairman and Chief Executive Officer of Able Laboratories, Inc. "Today's announcement follows our receipt yesterday of FDA approval for our generic version of Darvocet-N(R). In addition, we have now obtained ANDA approvals for generic versions of Ritalin SR(R), Ritalin(R), Lomotil(R), Soma(R) and Darvocet-N(R) and one New Drug Application (NDA) approval. The total market for our recently approved products is estimated at $1.2 billion by IMS Data. Additionally, we currently have eight ANDAs pending approval, several of which we anticipate within the next few months." Able Laboratories (OTCBB:ABRX) is a rapidly growing developer and manufacturer of generic pharmaceuticals. Able's focus is to develop products that offer attractive market opportunities within selected niche markets of the generic drug industry. In addition to the one new drug application approval that the company recently received, it has obtained seven ANDA approvals and has several ANDAs in various stages of FDA approval. Able has recently completed its transition to focus the company's activities solely on generic drug development, manufacturing and sales by divesting its distribution subsidiaries. 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 Able Laboratories, Inc. f/k/a DynaGen, Inc.) contain statements that are forward-looking, such statements relate to anticipated future revenues of the company success of current product offerings, research and development efforts and the timeliness of Food and Drug Administration (FDA) filings and approvals. There is no assurance that the company will achieve the sales levels that will make the operation profitable or that FDA filings and approvals will be completed as anticipated. Such forward-looking information involves important 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 Able Laboratories, Inc. f/k/a DynaGen, Inc. For a description of additional risks, and uncertainties, please refer to Able Laboratories, Inc. f/k/a DynaGen, Inc. filings with the Securities and Exchange Commission, including Forms 10 -KSB and 10-Q. Compazine is a registered trademark of Smithkline Beecham Pharmaceuticals. Darvocet-N is a registered trademark of Eli Lilly. Lomotil is a registered trademark of G. D. Searle Ritalin and Ritalin SR are registered trademarks of Novartis Soma is a registered trademark of Wallace Laboratories |
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