Tue Dec 24, 2013 9:56am EST
<span id="articleText"> <span id="midArticle_0"/>Dec 24 (Reuters) - Actavis Plc said U.S. health regulators denied approval to its contraceptive patch for women and asked for more data.
<span class="articleLocatio/spann"/>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.
<span id="midArticle_2"/>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.
<span id="midArticle_3"/>Such letters typically lay out FDA concerns that need to be addressed before a treatment is approved.
<span id="midArticle_4"/>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.
<span id="midArticle_5"/>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.
<span id="midArticle_6"/>The treatment will compete with Johnson and Johnson's Ortho Evra, an estrogen/progestin combination contraceptive patch. Estrogen is another female sex hormone.
<span id="midArticle_7"/>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.
<span id="midArticle_8"/>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 ring.
<span id="midArticle_9"/>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.
<span id="midArticle_10"/>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.
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<span id="articleText"> <span id="midArticle_0"/>Dec 24 (Reuters) - Actavis Plc said U.S. health regulators denied approval to its contraceptive patch for women and asked for more data.
<span class="articleLocatio/spann"/>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.
<span id="midArticle_2"/>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.
<span id="midArticle_3"/>Such letters typically lay out FDA concerns that need to be addressed before a treatment is approved.
<span id="midArticle_4"/>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.
<span id="midArticle_5"/>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.
<span id="midArticle_6"/>The treatment will compete with Johnson and Johnson's Ortho Evra, an estrogen/progestin combination contraceptive patch. Estrogen is another female sex hormone.
<span id="midArticle_7"/>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.
<span id="midArticle_8"/>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 ring.
<span id="midArticle_9"/>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.
<span id="midArticle_10"/>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.
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