Business Services Industry
Able Laboratories Receives ANDA Approval for Tramadol Hydrochloride Tablets; Generic Version to be Marketed by IVAX Pharmaceuticals
Business Wire, July 3, 2002
Business Editors & Health/Medical Writers
Able Laboratories, Inc. (OTCBB:ABLA) (BSE:ABRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Tablets, 50mg. The total market for Able's newly approved drug, an AB-rated generic version of R.W. Johnson's Ultram(R), is approximately $550 million according to the IMS Data.
Earlier in the year, Able Labs announced that it entered into an ANDA Transfer and Marketing Agreement with IVAX Pharmaceuticals, Inc. a wholly owned subsidiary of IVAX Corporation (AMEX:IVX) (LSE:IVX.L) for Able Labs' Tramadol Hydrochloride Tablets. Under the terms of the agreement, Able Labs will manufacture and supply the product exclusively to IVAX under their label and IVAX will exclusively sell Able Labs' manufactured product.
Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 14 ANDA approvals. The Company has completed its transition to focus its activities on generic drug development, manufacturing and sales. 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 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 three months ended March 31, 2002. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments.
Most Recent Business Articles
- Your feedback
- Why fly solo when an executive assistant can accelerate your CLNC® business?
- The CLNC® mentors held the key to my first case and to my CLNC® success
- Atlanta CLNC® 6-day certification seminar photo galleryplus sign up today for spring 2009 to save $100.00
- Announcing the 2009 NACLNC® conference keynote speaker, Stedman Graham: move like a maverick for breakaway CLNC® success at the 2009 NACLNC® conference
Most Recent Business Publications
Most Popular Business Articles
- Using object-oriented analysis and design over traditional structured analysis and design
- Big Fish Games Migrates Upstream to Fisher Plaza; High Growth Online Gaming Firm Vaults Fisher Plaza Occupancy Rate Above 90%
- Top of the line: some of the world's most well-respected doctors practice in South Florida. A guide to choosing the best physician specialists - Top Doctors in South Florida
- BEHR Paints Introduces a Colorful New Way to Paint and Prime All in One with BEHR Premium Plus Ultra™ Interior
- Sand filter basics: high-rate sand filters can be confusing for those new to the business. Understanding valve modes is the key

