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FDA Approves Activella (Estradiol/Norethindrone) For Prevention Of
Postmenopausal Osteoporosis
PEAPACK, N.J-- April 14, 2000 -- Pharmacia Corporation announced that
the U.S. Food and Drug Administration (FDA) has approved
Activella(TM), (estradiol/norethindrone acetate tablets) for the
prevention of osteoporosis associated with menopause.
Osteoporosis is a condition marked by a decrease in bone mineral
density (BMD), which causes bones to become fragile, increasing the
risk of fractures.
The osteoporosis indication was approved based on the results of two
randomized, placebo controlled, two-year clinical trials involving 462
postmenopausal women in the U.S. and Europe. The studies found
Activella to be effective in preventing bone loss in postmenopausal
women compared to the placebo group, based on measurement of various
skeletal sites, including the lumbar spine and total hip.
Activella is a continuous-combined once daily tablet combining
estrogen (1 mg estradiol) and progestin (0.5 mg norethindrone
acetate). It was previously approved by the FDA for the treatment of
moderate to severe vasomotor symptoms associated with menopause and
for vulvar and vaginal atrophy associated with menopause. Use of the
product is restricted to women with an intact uterus.
A debilitating and sometimes life-threatening disease, osteoporosis --
or porous bone -- is a major public health threat for more than 28
million Americans -- 80 percent comprised of women. It is
characterized by low bone mass and structural deterioration of bone
tissue, leading to bone fragility and an increased susceptibility to
fractures of the hip, spine and wrist. At menopause, a woman
experiences bone loss, which increases her risk for bone fractures.
Bone fractures are a major cause of morbidity and mortality associated
with osteoporosis.
In January of 2000, Pharmacia acquired the U.S. rights to Activella
from Novo Nordisk A/S. Under terms of the agreement, Pharmacia also
acquired the rights to Vagifem(R) (estradiol vaginal tablet, USP),
approved in the U.S. for the treatment of atrophic vaginitis resulting
from estrogen deficiency; and Innofem(TM) (estradiol tablet, USP), an
estrogen-only product approved in the U.S. for a variety of
indications associated with hormone treatment and estrogen
replacement.
Activella will be available in pharmacies by summer 2000.
Estrogen replacement therapy (ERT) and HRT are not suitable for
everyone, including women with known or suspected pregnancy, breast
cancer, estrogen- dependent neoplasia, active deep vein thrombosis,
thromboembolic disorders or stroke, undiagnosed genital bleeding or
liver dysfunction or disease. Anyone who has hypersensitivity to any
of the components of Activella should not take it. Common side effects
may include breast tenderness/pain, upper respiratory complaints,
headache and postmenopausal bleeding.
Pharmacia Corporation is marketing Activella under an exclusive
licensing agreement with Novo Nordisk A/S.
Related links: Pharmacia Corporation.
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