Interpharm Announces FDA Approval of Hydrocodone Bitartrate and Ibuprofen 5/200
mg Tablets, a New Dosage Strength of the Generic Bioequivalent of Vicoprofen(R) COMMACK, N.Y., March 23 /PRNewswire-FirstCall/ -- Interpharm Holdings, Inc.
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 .
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 acontract 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, http://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. DATASOURCE: Interpharm Holdings, Inc.
CONTACT: George Aronson of Interpharm Holdings, Inc., +1-631-952-0214, ext. 101, Web site: http://www.interpharminc.com/
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