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Cervical Cancer Vaccine Receives Approval
Merck and Company, Inc, received approval from the US Food and
Drug Administration (FDA) for its quadrivalent human papillomavirus
types 6,11,16,18, recombinant vaccine (Gardasil). The vaccine,
which is available immediately, is administered via three intramuscular
injections in the upper arm over a 6-month period. The vaccine
is approved for women aged 9 to 26 years. Human papillomavirus
types 16 and 18 account for an estimated 70% of cervical cancer
cases, and types 6 and 11 account for an estimated 90% of genital
wart cases. The vaccine represents a major step in the prevention
of cervical cancer; genital warts; low-grade cervical lesions;
and cervical, vaginal, and vulvar precancers.
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New Options in Extended-cycle Contraception
Barr Pharmaceuticals, Inc, and subsidiary company Duramed Pharmaceuticals,
Inc, have announced the FDA approval of its newest extended-cycle
levonorgestrel (LNG)/ethinyl estradiol (EE) oral contraceptive
(Seasonique). With this new extended-cycle regimen, users take
84 days of combination therapy (LNG 0.15 mg/EE 0.03 mg), followed
by 7 days of unopposed estrogen (EE 0.01 mg), reducing the number
of withdrawal bleeding periods from monthly to four times per year.
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Alleviating Lesions
Associated With Rosacea
The first orally-administered drug indicated for rosacea in adults,
doxycycline (Oracea), has been approved by the FDA. Taken once a day, each
40-mg capsule contains 30-mg immediate-release, and 10-mg delayed-release
beads. The approval is based on results of two phase 3, multicentered, double-blind,
placebo-controlled clinical trials with a total enrollment of 537
patients. The two studies showed a 61% and 46% mean reduction of
inflammatory lesions in patients receiving doxycycline, compared with 29%
and 20% with placebo. Doxycycline is indicated only to treat inflammatory
lesions (papules and pustules) of rosacea, and is not indicated for the treatment
of general erythema.
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Innovative Endometrial Biopsy Pipette
The FDA has approved FemSuite’s new endometrial biopsy pipette (FemTest).
Unlike traditional pipettes, the device features a unique cone-shaped, silicon
stop-cock which seals the cervix, allowing for the injection of liquids or
gels into the uterus prebiopsy, where the cone-shaped stop-cock keeps the
liquids and gels in place.
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Vaccinating
Against Shingles
Merck’s novel zoster vaccine live (Zostavax) for the prevention of herpes
zoster has been approved by the FDA. In a double-blind, placebo-controlled
study conducted by Merck and Company, Inc, in conjunction with the Department
of Veterans Affairs and the National Institute of Allergy and Infectious Diseases,
zoster vaccine live reduced the risk of developing shingles by 51% compared
with placebo. Zoster vaccine live is indicated for the prevention of herpes
zoster in individuals aged 60 years and older.
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