Akorn-Strides, LLC Announces FDA Approvals for Dexamethasone Sodium Phosphate Injection...

* Reuters is not responsible for the content in this press release.

Tue Sep 2, 2008 7:00am EDT

Akorn-Strides, LLC Announces FDA Approvals for Dexamethasone Sodium Phosphate Injection USP, 4 mg (base)/mL and Dexamethasone Sodium Phosphate Injection USP, 10 mg (base)/mL

BUFFALO GROVE, Ill.--(Business Wire)--
Akorn-Strides, LLC today announced the approval of two ANDAs for
Dexamethasone Sodium Phosphate Injection USP, 4 mg (base)/mL in 1mL, 5
mL, and 30 mL vials, and Dexamethasone Sodium Phosphate Injection USP,
10 mg (base)/mL in 10 mL vials. Akorn-Strides, LLC is a Joint Venture
that was formed in 2005 by Akorn, Inc. (NASDAQ: AKRX) and Strides
Arcolab Limited (NSE: STAR)(BSE: 532531). The primary mission of the
Joint Venture is to develop liquid, lyophilized and dry powder
formulations of generic injectable products targeting several
therapeutic markets with a major focus on anti-infectives, analgesics
and CNS medicines.

   Dexamethasone Sodium Phosphate Injection is indicated to treat
various conditions such as endocrine disorders, arthritis, blood
disorders, dermatologic diseases, severe allergic reactions, eye
diseases, certain cancers, gastrointestinal diseases and respiratory
diseases. Recent IMS data estimates an annual market size for
Dexamethasone of approximately $28 million.

   The current product portfolio of the Joint Venture, which is
funded equally by Akorn and Strides Arcolab, was recently expanded and
now includes 29 ANDAs with a total of 53 SKU's, or product line
offerings. To date, the Joint Venture has filed for 18 ANDAs and
received 11 ANDA approvals. The Joint Venture has generated product
revenue in the third quarter of 2008 from its initial product launch
of Rifampin for Injection.

   In a statement given by Arthur S. Przybyl, President and CEO of
Akorn and Member Manager of Akorn-Strides, LLC, "We are excited to
announce these two ANDA product approvals for Dexamethasone Sodium
Phosphate Injection."

   About Akorn, Inc.

   Akorn, Inc. manufactures and markets sterile specialty
pharmaceuticals. Akorn has manufacturing facilities located in
Decatur, Illinois and Somerset, New Jersey and markets and distributes
an extensive line of hospital and ophthalmic pharmaceuticals.
Additional information is available at the Company's website at
www.akorn.com.

   About Strides Arcolab Limited

   Strides, listed on the Bombay Stock Exchange Limited (532531) and
National Stock Exchange of India Limited (STAR), is one of India's
largest exporters of branded generic pharmaceutical products. Strides
manufactures pharmaceutical formulations in various dosage forms,
including capsules, tablets and liquid injectables and is one of the
world's top five manufacturers of softgel capsules. Strides also has
the only globally dedicated softgel facility for hormones. In
addition, Strides undertakes contract research and the manufacturing
of specialty chemicals for various multinational companies. Strides
has a major presence in various developing countries such as Africa,
Latin America and Asia as well as in developed markets such as the
U.S., Canada and part of Europe. Strides is one of the largest Indian
suppliers of institutionally funded aid projects and is an approved
supplier to the Global Drug Facility, UNICEF, and MSF amongst others.

   Strides has 14 manufacturing plants spread across the U.S.,
Brazil, Mexico, Italy, Poland, Singapore and India. This broad
manufacturing network facilitates partnering with global organizations
ranging from UNICEF and WHO-Global Drug Facility to European and
American pharmaceutical multinationals, private labelers and
distribution chains. Strides has product registrations in over 37
countries around the world and has earned ISO 9001, ISO 14001 and GMP
accreditations including USFDA. Strides employs approximately 1,700
people across the globe. Strides also has a marketing presence in over
50 countries.

   Materials in this press release may contain information that
includes or is based upon forward-looking statements within the
meaning of the Securities Litigation Reform Act of 1995.
Forward-looking statements give our expectations or forecasts of
future events. You can identify these statements by the fact that they
do not relate strictly to historical or current facts. They use words
such as "anticipate," "estimate," "expect," "project," "intend,"
"plan," "believe," and other words and terms of similar meaning in
connection with a discussion of future operating or financial
performance. In particular, these include statements relating to
future steps we may take, prospective products, future performance or
results of current and anticipated products, sales efforts, expenses,
the outcome of contingencies such as legal proceedings, and financial
results.

   Any or all of our forward-looking statements here or in other
publications may turn out to be wrong. They can be affected by
inaccurate assumptions or by known or unknown risks and uncertainties.
Many such factors will be important in determining our actual future
results. Consequently, no forward-looking statement can be guaranteed.
Our actual results may vary materially, and there are not guarantees
about the performance of our stock.

   Any forward-looking statements represent our expectations or
forecasts only as of the date they were made and should not be relied
upon as representing our expectations or forecasts as of any
subsequent date. We undertake no obligation to correct or update any
forward-looking statements, whether as a result of new information,
future events or otherwise, even if our expectations or forecasts
change. You are advised, however, to consult any further disclosures
we make on related subjects in our reports filed with the SEC. In
particular, you should read the discussion in the section entitled
"Cautionary Statement Regarding Forward-Looking Statements" in our
most recent Annual Report on Form 10-K, as it may be updated in
subsequent reports filed with the SEC. That discussion covers certain
risks, uncertainties and possibly inaccurate assumptions that could
cause our actual results to differ materially from expected and
historical results. Other factors besides those listed there could
also adversely affect our results.

Company Contact:
847-279-6100

Copyright Business Wire 2008
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.