Endo Pharmaceuticals Gives Update on Regulatory Status of FORTESTA(TM)

CHADDS FORD, Pa., Oct. 19 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals
(Nasdaq: ENDP) today announced that it received a Complete Response letter
from the U.S. Food and Drug Administration (FDA) regarding the New Drug
Application (NDA) for FORTESTA(TM) (testosterone) 2% Gel for men diagnosed
with low testosterone (Low T), also known as hypogonadism.

"The potential of this action was considered in the structure of the deal to
in-license this product," said Dr. Ivan Gergel, M.D., executive vice
president, R&D, Endo Pharmaceuticals. "We will continue to work closely with
the FDA to address their questions and we expect to file a complete response,
mid-2010. Endo is committed to bringing FORTESTA to market to offer men
another option for testosterone replacement therapy."

In August 2009, Endo signed an agreement with U.K.-based ProStrakan Group Plc
to acquire exclusive U.S. rights to commercialize the testosterone 2% gel,
branded variously as Tostran, Tostrex and Itnogen outside the U.S. The
testosterone 2% gel is marketed across Europe by ProStrakan's own, in-house
sales forces and is out-licensed by ProStrakan to Bayer Schering Pharma (BSP)
in 147 countries.

LOW T
Low T, also known as hypogonadism, is a condition in men characterized by the
body's failure to produce normal amounts of the hormone testosterone. It is
associated with symptoms including decreased energy and mood, fatigue, loss of
muscle mass, decreased libido and erectile dysfunction. In addition, there is
increasing evidence of the link between Low T and other serious medical
conditions including diabetes, cardiovascular disease and metabolic syndrome.
Because the symptoms of Low T are often similar to those caused by other
medical conditions, more than 91 percent of men with the condition go
undiagnosed.

About Endo
Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the
research, development, sale and marketing of branded and generic prescription
pharmaceuticals used to treat and manage pain, overactive bladder, prostate
cancer and the early onset of puberty in children, or central precocious
puberty (CPP). Its products include LIDODERM®, a topical patch to relieve the
pain of postherpetic neuralgia; Percocet® and Percodan® tablets for the relief
of moderate-to-moderately severe pain; FROVA® tablets for the acute treatment
of migraine attacks with or without aura in adults; OPANA® tablets for the
relief of moderate-to-severe acute pain where the use of an opioid is
appropriate; OPANA® ER tablets for the relief of moderate-to-severe pain in
patients requiring continuous, around-the-clock opioid treatment for an
extended period of time; Voltaren® Gel, which is owned and licensed by
Novartis AG, a nonsteroidal anti-inflammatory drug indicated for the relief of
the pain of osteoarthritis of joints amenable to topical treatment, such as
those of the hands and the knees; VANTAS® for the palliative treatment of
advanced prostate cancer; SUPPRELIN® LA for the treatment of early onset
puberty in children; and VALSTAR(TM) for the treatment of BCG-refractory
carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate
cystectomy would be associated with unacceptable medical risks. The company
markets its branded pharmaceutical products to physicians in pain management,
urology, endocrinology, oncology, neurology, surgery and primary care. More
information, including this and past press releases of Endo Pharmaceuticals,
is available at www.endo.com.

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the Private Securities Litigation Reform Act of 1995 regarding, among other
things, the company's financial position, results of operations, market
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uncertainties. Investors should note that many factors could affect our future
financial results and could cause our actual results to differ materially from
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These factors include, but are not limited to those detailed from time to time
in our periodic reports filed with the Securities and Exchange Commission,
including our current reports on Form 8-K, quarterly reports on Form 10-Q and
annual reports on Form 10-K, particularly the discussion under the caption
"Item 1A, RISK FACTORS" in our annual report on Form 10-K for the year ended
December 31, 2008, which was filed with the Securities and Exchange Commission
on March 2, 2009. The forward-looking statements in this press release are
qualified by these risk factors. These are factors that, individually or in
the aggregate, we think could cause our actual results to differ materially
from expected and historical results. We assume no obligation to publicly
update any forward-looking statements, whether as a result of new information,
future developments or otherwise.
SOURCE Endo Pharmaceuticals

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