U.S. Food and Drug Administration (FDA) Denies Abbott's Citizen Petition Regarding Levothyroxine Sodium Products
24 Juin 2004 - 5:08AM
PR Newswire (US)
U.S. Food and Drug Administration (FDA) Denies Abbott's Citizen
Petition Regarding Levothyroxine Sodium Products - Company Confirms
Previously Announced EPS Guidance for 2004 - ABBOTT PARK, Ill.,
June 23 /PRNewswire-FirstCall/ -- Abbott Laboratories was informed
today by the U.S. Food and Drug Administration (FDA) that it has
denied the Citizen Petition that Abbott filed at the FDA's request
in August 2003 regarding bioequivalence of levothyroxine sodium
products. SYNTHROID(R) (levothyroxine sodium tablets, USP),
Abbott's thyroid medication, is now subject to generic competition.
SYNTHROID is the second-most-prescribed drug in the United States.
"Millions of patients and their physicians have relied on SYNTHROID
as a trusted therapy for a half century," said Jeffrey M. Leiden,
M.D., Ph.D., president and chief operating officer, Pharmaceutical
Products Group, Abbott Laboratories. "SYNTHROID is also one of the
least expensive medications -- branded or generic -- on the market
today. Abbott is committed to continuing to make SYNTHROID
available to patients." The relative cost for SYNTHROID is
remarkably low. For example, the cost of the most common daily
SYNTHROID strength (100mcg) is only approximately 70 cents at
retail. Additionally, SYNTHROID is available for low-income seniors
and other eligible Medicare beneficiaries for $5 per monthly
prescription through Abbott's expanded Medicare Assistance Program.
Abbott Confirms Previously Announced EPS Guidance for 2004 The
company is confirming its previously announced guidance for
earnings-per-share from continuing operations, excluding one-time
charges, of $2.24 to $2.31 for the full year 2004, and for the
second quarter of $0.53 to $0.55. These guidance ranges incorporate
the possible impact of generic competition on SYNTHROID sales.
Abbott anticipates one-time charges for the Hospira spin-off and
acquisitions related to earnings-per-share from continuing
operations of approximately $0.22 per share for the full-year, and
$0.13 per share for the second quarter. Abbott notes that in
accordance with Securities and Exchange Commission (SEC) Regulation
G, projected earnings-per-share from continuing operations under
Generally Accepted Accounting Principles (GAAP) would be $2.02 to
$2.09 for the full year, and $0.40 to $0.42 for the second quarter.
SYNTHROID(R) Indication and Safety Information SYNTHROID is
indicated as replacement or supplemental therapy for primary,
secondary, tertiary and subclinical hypothyroidism. SYNTHROID is
not indicated for transient hypothyroidism during recovery of
subacute thyroiditis. Thyroid hormones, including SYNTHROID, either
alone or with other therapeutic agents, should not be used for the
treatment of obesity or for weight loss. In euthyroid patients,
doses within the range of daily hormonal requirements are
ineffective for weight reduction. Larger doses may produce serious
or even life threatening manifestations of toxicity, particularly
when given in association with sympathomimetic amines such as those
used for their anorectic effects. Levothyroxine is contraindicated
in patients with untreated subclinical or overt thyrotoxicosis,
acute myocardial infarction, uncorrected adrenal insufficiency, or
with hypersensitivity to any of the inactive tablet ingredients.
Levothyroxine should not be used in the treatment of male or female
infertility unless this condition is associated with
hypothyroidism. Use with caution in patients with underlying
cardiovascular disease. Adverse reactions associated with
levothyroxine therapy are primarily those of hyperthyroidism due to
therapeutic overdosage. If a patient experiences any unusual
symptoms, a healthcare provider should be contacted. The thyroid, a
butterfly-shaped gland located in the neck just below the Adam's
apple and above the collarbone, produces hormones that influence
essentially every organ, tissue and cell in the body. Thyroid
disease affects an estimated 13 million Americans, but
approximately half do not know they have the condition. Women are
five times more likely than men to develop hypothyroidism. Further
information, including SYNTHROID full prescribing information, is
available at http://www.synthroid.com/ or by calling 1 (800)
255-5162. About Abbott Laboratories Abbott Laboratories is a
global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics.
The company employs more than 55,000 people and markets its
products in more than 130 countries. Abbott's news releases and
other information are available on the company's Web site at
http://www.abbott.com/. Private Securities Litigation Reform Act of
1995 - A Caution Concerning Forward-Looking Statements Some
statements in this news release may be forward-looking statements
for the purposes of the Private Securities Litigation Reform Act of
1995. We caution that these forward-looking statements are subject
to risks and uncertainties that may cause actual results to differ
materially from those indicated. Economic, competitive,
governmental, technological and other factors that may affect
Abbott's operations are discussed in Exhibit 99.1 of our 2003
Annual Report on Securities and Exchange Commission Form 10-K, and
are incorporated by reference. We undertake no obligation to
release publicly any revisions to forward-looking statements as the
result of subsequent events or developments. DATASOURCE: Abbott
Laboratories CONTACT: Media: Catherine Bryan, +1-847-938-8551, or
cell, +1-312-209-0250, or Laureen Cassidy, +1-847-938-7743, or
cell, +1-847-772-1987, Jennifer Smoter, +1-847-935-8865, or
Financial Community: John Thomas, +1-847-938-2655, or Larry Peepo,
+1-847-935-6722, all of Abbott Laboratories Web site:
http://www.abbott.com/ http://www.synthroid.com/ Company News
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