Dec 24 Actavis Plc said U.S. health
regulators denied approval to its contraceptive patch for women
and asked for more data.
The U.S. Food and Drug Administration questioned the
differences in size and formulation of the patch used in trials
and the to-be-marketed patch.
The generic drugs maker, which received a "complete response
letter" from the FDA, said it planned to work closely with the
agency to address the questions.
Such letters typically lay out FDA concerns that need to be
addressed before a treatment is approved.
Actavis' contraceptive skin patch is designed to provide
continuous delivery of the hormone norethindrone, a type of
progestin, during a once-weekly, seven-day dosing regimen.
Progestin, the synthetic form of female sex hormone
progestogen, inhibits ovulation and thickens the layer of mucus
at the cervix so sperm cannot enter the uterus.
The treatment will compete with Johnson and Johnson's
Ortho Evra, an estrogen/progestin combination
contraceptive patch. Estrogen is another female sex hormone.
A progestin-only patch can be safer than combination patches
as high levels of estrogen are often linked to blood clotting
disorders and an increased risk of cancer.
The company also filed on Tuesday an application to market
the generic version of Merck & Co Inc's NuvaRing, a
estrogen/progestin combination hormonal contraceptive vaginal
Actavis said it may be the first applicant to file the
application, which, if approved may entitle it to 180 days of
generic market exclusivity.
Shares of Dublin, Ireland-based Actavis were down 0.6
percent at $165.16 in early trading on the New York Stock
Exchange on Tuesday.