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Able Laboratories Receives its First FDA New Drug Application Approval; New Drug Combination Provides Unique Packaging to Treat Urinary Tract Infections.

Business Editors/Health & Medical Writers


Able Laboratories Inc. (OTCBB:ABRX), today announced it has received Food and Drug Administration (FDA) approval for its first-ever New Drug Application (NDA) for its unique product for the treatment of urinary tract infections (UTIs). It is the first branded therapeutic drug developed by Able Laboratories, the NDA application for which was filed in the first quarter of 1999. This specialty pharmaceutical product provides enhanced packaging to the patient in the form of a single blister pack containing both an antibiotic to treat the infection, and a urinary analgesic to relieve the symptoms.

Able's new specialty pharmaceutical product is aimed at providing a complete treatment for urinary tract infections, a condition that primarily afflicts women. Current treatments necessitate two separate drugs for the treatment of the infection and its associated symptoms. This may require separate prescriptions, resulting in higher costs including co-payment cost for the patient, and increased dispensing time for the pharmacist. Able's product combines the two most commonly used drugs for treating UTIs -- sulfamethoxazole-trimethoprim and phenazopyridine, in an easy-to-use package that enhances compliance. Studies have shown that, in general, combination packaging enhances compliance, resulting in increased efficacy. When patients take their prescription correctly, they are more likely to have a positive response to the medication, which results in reduced hospital admissions, decreased physician visits and reduced laboratory use, with an end result of substantial overall savings in health care costs.

"Our goal with this product is to provide an effective and efficient treatment for the patient," stated C. Robert Cusick, Chairman and Chief Executive Officer of Able Laboratories, Inc. "Our new product allows a patient to take -- in one combination pack -- the antibiotic to treat the infection along with the drug to relieve the associated pain and symptoms. And, instead of two prescriptions, the patient only has one prescription to fill, thereby reducing their costs as well as their insurance companies' expense.

"This is an important approval for us since it is our first FDA approved brand drug," continued Cusick. "We have obtained this approval, along with four ANDA approvals, within the last six months. These approvals and our other 11 pending FDA filings are the result of the Research and Development (R&D) investments we have made over the last two to three years."

Able Laboratories (OTCBB:ABRX), is a rapidly growing developer and manufacturer of generic pharmaceuticals. The focus of the company is to develop products that offer attractive market opportunities within selected niche markets of the generic drug industry. In addition to the eight products it is currently selling, the company has 11 products in various stages of FDA approval. The company has completed its transition that focuses 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 related to anticipated future revenues of the companies, success of current product offerings, research and development efforts and the timeliness of Federal 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. For a description of additional risks, and uncertainties, please refer to DynaGen, Inc. or Able Laboratories, Inc. filings with the Securities and Exchange Commission, including Forms 10K and 10Q.
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Publication:Business Wire
Date:Jun 26, 2001
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