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Able Laboratories Receives FDA Approval for Propoxyphene Napsylate and Acetaminophen 100 Mg and 650 Mg Tablets.

Business Editors/Health & Medical Writers


Generic Version of Darvocet-N(R) With Estimated

Generic Market of $450 Million

Able Laboratories, Inc. (OTCBB:ABRX), today announced it has received Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Propoxyphene Napsylate and Acetaminophen Tablets USP 100 mg and 650 mg. The approval followed the FDA's Division of Bioequivalence's determination that Able's Propoxyphene Napsylate and Acetaminophen Tablets USP, 100 mg and 650 mg, are bioequivalent and, therefore, therapeutically equivalent to the Darvocet-N(R) 100 mg and 650 mg Tablets of Eli Lilly. The generic market for Able's newly approved drug, an analgesic combination used to relieve pain, is estimated to be $450 million by IMS Data. Able anticipates shipment of the product will commence immediately.

"This is an important approval for us," stated C. Robert Cusick, Chairman and Chief Executive Officer of Able Laboratories, Inc. "The generic market for this drug is substantial and we believe we will be able to achieve quick market acceptance and, hence, market share. In addition to a New Drug Approval that we received last month, we have obtained 5 ANDA approvals in the last six months and we currently have ten ANDAs pending approval, several of which we anticipate very soon. Our R&D efforts have produced this ANDA pipeline and we look forward to introducing a steady flow of newly approved products in the coming quarters."

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 five 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 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.

Darvocet-N is a registered trademark of Eli Lilly
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Publication:Business Wire
Date:Jul 12, 2001
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