Able Laboratories Receives FDA Approval for Carisoprodol Tablets USP ...
SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--June 22, 2001
Able Laboratories, Inc. (OTCBB:ABRX) today announced it has received Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Carisoprodol carisoprodol /car·iso·pro·dol/ (kar?i-so-pro´dol) an analgesic and skeletal muscle relaxant
1. lessening or reducing tension.
2. an agent that so acts.
muscle relaxant an agent that specifically aids in reducing muscle tension.
re·lax·ant (r used to relieve symptoms of acute painful skeletomuscular disorders. Tablets USP USP - Unit Sales Price
USP - United States Pharmacopeia (United States Pharmacopeial Convention, Inc.)
USP - Ubiquitin-Specific Protease
USP - Unique Sales Proposition
USP - Unique Selling Point
USP - Unique Selling Proposition
USP - United States Patent
USP - United States Penitentiary
USP - United States Postage
USP - United Steel Products
USP - Universal Sampling Plan
USP - Universal Self-loading Pistol
USP - Universal Serial Port 350 mg. The approval followed the FDA's Division of Bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability.bioequiv´alent's determination that Able's Carisoprodol Tablets USP, 350 mg. are bioequivalent and, therefore, therapeutically equivalent to the Soma soma /so·ma/ (so´mah)
1. the body as distinguished from the mind.
2. the body tissue as distinguished from the germ cells.
3. the cell body.
so·ma (R) 350 mg Tablets of Wallace Laboratories. The generic market for Able's newly approved drug, mainly used as a muscle relaxant and for muscle spasms muscle spasm
n.
, is estimated to be $260 million by IMS Data. Able filed its ANDA for Carisoprodol Tablets USP, 350 mg. in October 2000. Persistent increased tension and shortness in a muscle or group of muscles that cannot be released voluntarily.
"This is the fourth FDA approval we have received in the last six months," stated C. Robert Cusick, Chairman and Chief Executive Officer of Able Laboratories, Inc. "These approvals and our other eleven pending FDA filings are the result of the Research and Development (R&D) investments we have made over the last two to three years. We have not stopped our R&D efforts. We will continue to have a consistent flow of new products over the quarters and years to come."
Able Laboratories (OTCBB:ABRX), formerly DynaGen, Inc., 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 generic drug, a drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name. The name of the active ingredient is established by a government or international body, and is typically the U.S. Adopted Name, British Approved Name, or International Nonproprietary Name. industry. In addition to the eight products it is currently selling, the Company has eleven 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 10-KSB and 10-Q.
Soma is a registered trademark of WallaceLaboratories.