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JERUSALEM--(BUSINESS WIRE)--Mar. 16, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the launch of the Authorized Generic of Minastrin®
24 Fe1 (norethindrone acetate and ethinyl estradiol tablets
and ferrous fumarate tablets) 1 mg/20 mcg in the U.S.
The Authorized Generic of Minastrin® 24 Fe is an
estrogen/progestin combined oral contraceptive indicated for use by
women to prevent pregnancy.
This Authorized Generic of Minastrin® 24 Fe adds to Teva’s
existing portfolio of more than 50 oral contraceptives. In the U.S., one
of every two oral contraceptive prescriptions is filled with a product
marketed by Teva.2
With nearly 600 generic medicines available, Teva has the largest
portfolio of FDA-approved generic products on the market and holds the
leading position in first-to-file opportunities, with over 100 pending
first-to-files in the U.S. Currently, one in six generic prescriptions
dispensed in the U.S. is filled with a Teva generic product.
Minastrin® 24 Fe had annual sales of approximately $361
million in the U.S. according to IMS data as of December 2016.3
About the Authorized Generic of Minastrin®
24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous
INDICATIONS AND USAGEThe Authorized Generic of Minastrin®
24 Fe is an estrogen/progestin combination oral contraceptive (COC)
indicated for use by females of reproductive age to prevent pregnancy.
Efficacy in women with a body mass index (BMI) of more than 35 kg/m2 has
not been evaluated.
IMPORTANT SAFETY INFORMATION
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular
events from combination oral contraceptive (COC) use. This risk
increases with age, particularly in women over 35 years of age,
and with the number of cigarettes smoked. For this reason, COCs
should not be used by women who are over 35 years of age and smoke.
ContraindicationsThe Authorized Generic of Minastrin®
24 Fe is contraindicated in pregnant patients, and those with a high
risk of arterial or venous thrombotic diseases, liver tumors (benign or
malignant) or liver disease, undiagnosed abnormal uterine bleeding, or
breast cancer or other estrogen- or progestin-sensitive cancer, now or
in the past.
Warnings and PrecautionsDiscontinue norethindrone acetate
and ethinyl estradiol tablets and ferrous fumarate tablets if a
thrombotic event occurs, and at least 4 weeks before and through 2 weeks
after major surgery. Norethindrone acetate and ethinyl estradiol tablets
and ferrous fumarate tablets should not be started any earlier than 4
weeks after delivery, in women who are not breastfeeding. If jaundice
occurs, treatment should be discontinued.
The Authorized Generic of Minastrin® 24 Fe
should not be prescribed for women with uncontrolled hypertension or
hypertension with vascular disease. Women who are prediabetic or
diabetic, should be monitored while using the Authorized Generic of
Minastrin® 24 Fe. Alternate contraceptive
methods should be considered for women with uncontrolled dyslipidemia.
Patients using the Authorized Generic of Minastrin®
24 Fe who have a significant change in headaches or irregular
bleeding or amenorrhea should be evaluated.
Adverse ReactionsIn the clinical trial for the
Authorized Generic of Minastrin® 24 Fe, the
most common adverse reactions (incidence ≥2%) were headache, vaginal
candidiasis, nausea, menstrual cramps, breast tenderness, bacterial
vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.
Patients should be counseled that COCs do not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
see full Prescribing Information, including Boxed Warning.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200 million
patients in 100 markets every day. Headquartered in Israel, Teva is the
world’s largest generic medicines producer, leveraging its portfolio of
more than 1,800 molecules to produce a wide range of generic products in
nearly every therapeutic area. In specialty medicines, Teva has the
world-leading innovative treatment for multiple sclerosis as well as
late-stage development programs for other disorders of the central
nervous system, including movement disorders, migraine, pain and
neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva's net revenues in 2016 were $21.9 billion. For more information,
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This press release contains forward-looking statements, which are
based on management’s current beliefs and expectations and are subject
to substantial risks and uncertainties, both known and unknown, that
could cause our future results, performance or achievements to differ
significantly from that expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to such
differences include risks relating to:
and other factors discussed in our Annual Report on Form 20-F for the
year ended December 31, 2016 (“Annual Report”) and in our other filings
with the U.S. Securities and Exchange Commission (the “SEC”).
Forward-looking statements speak only as of the date on which they are
made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise. You
are advised to consult any additional disclosures we make in our reports
to the SEC on Form 6-K, as well as the cautionary discussion of risks
and uncertainties under “Risk Factors” in our Annual Report. These are
factors that we believe could cause our actual results to differ
materially from expected results. Other factors besides those listed
could also materially and adversely affect us. This discussion is
provided as permitted by the Private Securities Litigation Reform Act of
1 Minastrin® is a registered trademark of Allergan
Pharmaceuticals International Limited.2 IMS Health NPA
data as of November 2016.3 IMS Health NPA data as of
View source version on businesswire.com: http://www.businesswire.com/news/home/20170316006125/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.IR Contacts:United StatesKevin
C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR Contacts:IsraelIris Beck Codner,
972 (3) 926-7208orUnited StatesDenise Bradley,