-
Published: 29 November -0001
March 23, 2004
News Release: Interpharm Announces FDA Approval of Hydrocodone Bitartrate and Ibuprofen 5/200 mg Tablets, a New Dosage Strength of the Generic Bioequivalent of Vicoprofen(R) Interpharm Holdings, Inc. (Amex: IPA) today announced that the U.S. Food and Drug Administration has approved the Company's Abbreviated New Drug Application for Hydrocodone Bitartrate and Ibuprofen Tablets, 5 mg/200 mg. This product is a new lower strength version of Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg, which is the generic equivalent of the branded drug Vicoprofen(R).
Hydrocodone Bitartrate and Ibuprofen Tablets, 5 mg/200 mg is a narcotic analgesic and nonsteroidal anti-inflammatory drug used for short-term management of acute pain. The Company believes that this new dosage strength will fill a void in the market for individuals, such as elderly and young patients, who might exhibit a certain level of intolerance to the higher dosage of Hydrocodone Bitartrate. Interpharm is the first company to have obtained approval to manufacture Hydrocodone Bitartrate and Ibuprofen Tablets in the 5 mg/200 mg dosage.
Dr. Maganlal Sutaria, MD, Interpharm's Chief Executive Officer and Chairman of the Board of Directors stated, 'We are very proud to be the first to offer medical care providers a new dosage strength of Hydrocodone Bitartrate and Ibuprofen providing them and their patients a new option for the management of pain.'Dr. Sutaria continued, 'This product also represents the further diversification of our product line towards specialized drugs with specific markets. As we increase our drugs under development, we will focus on products which leverage our manufacturing efficiencies and continue to diversify our product line.'
For further information, please contact: George Aronson at 631-952-0214 extension 101, or, via e-mail, at
This email address is being protected from spambots. You need JavaScript enabled to view it. .
ABOUT INTERPHARM
Interpharm develops, manufactures and markets over 20 generic prescription strength and over-the-counter drugs. Over the two-year period ending December 31, 2003, Interpharm experienced revenue growth of approximately 82%, and net income growth of approximately 284%. Interpharm will continue to focus on growing organically through internal product development and leveraging its strength in efficient and cost effective manufacturing. Interpharm will also continue to seek consummation of mutually beneficial strategic alliances and collaborations. To accommodate Interpharm's anticipated growth, it has entered into a contract to acquire a production facility of approximately 100,000 square feet. This facility is on over thirty-seven acres of land, which will allow Interpharm the opportunity to increase production capacity in the future as the need arises. Interpharm has also significantly increased its research and development budget to accommodate its objective of increasing the number of drugs in development over the next twelve months.
For press releases and other information about Interpharm, please visit Interpharm's Web site, www.interpharminc.com.
FORWARD-LOOKING STATEMENTS
Statements made in this news release, may contain forward-looking statements concerning Interpharm's business and products involving risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. The actual results may differ materially depending on a number of risk factors including, but not limited to, the following: general economic and business conditions, development, shipment, market acceptance, and additional competition from existing and new competitors, changes in technology, and various other factors beyond Interpharm's control. Other risks inherent in Interpharm's business are described in ATEC Group, Inc.'s Definitive Proxy Statement, filed with the Securities and Exchange Commission on May 2, 2003, Form 10-K, filed on September 29, 2003 Forms 10-Q filed on November 14, 2003 and February 17, 2004, and the 'Management's Discussion and Analysis of Financial Condition and Results of Operations'sections contained therein. The acquisition of Interpharm, Inc. is described in the foregoing proxy materials, as well as in ATEC's Form 8-K, filed with the Securities and Exchange Commission on February 27, 2003, our Form 8-K, filed on June 16, 2003 and our amended Form 8-K, filed on August 11, 2003. Interpharm undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this release.
All information in this release is as of March 23, 2004. Interpharm undertakes no duty to update any forward-looking statements to conform the release to actual results or changes in its circumstances or expectations after the date of this release.
Vicoprofen(R) is a registered trademark of Abbott Laboratories.
SOURCE Interpharm Holdings, Inc.
George Aronson of Interpharm Holdings, Inc., +1-631-952-0214, ext. 101,
This email address is being protected from spambots. You need JavaScript enabled to view it. http://www.interpharminc.com
WEBSITE EMAIL