Norethindrone Acetate Patch
Description: Norethindrone acetate transdermal delivery system (patch).
Product Details
User: Female
Hormonal: Yes
Delivery Method: Transdermal
Duration Type: Short-acting
Duration: One week
Regimen: - weekly (3 weeks on, 1 week without patch)
- weekly (3 weeks on, 1 week without patch)
Active Pharmaceutical Ingredient (API): - norethindrone
- norethindrone
Multipurpose Preventive Technology (MPT): No
Status Details
Developer: Allergan
Project Phase: Limited Market Availability
Development Stage: Regulatory
Active Development: Yes
Status Details: - Phase III completed in 2012. NDA filed with US FDA in 2013. Received complete response letter from FDA in late 2013 (product was not approved).
- Phase III completed in 2012. NDA filed with US FDA in 2013. Received complete response letter from FDA in late 2013 (product was not approved).
Additional Information
Footnotes: - Phase III study conducted by Watson Pharmaceuticals, which is now Actavis. After Actavis bought out Allergan, Actavis began using the Allergan name.
- Phase III study conducted by Watson Pharmaceuticals, which is now Actavis. After Actavis bought out Allergan, Actavis began using the Allergan name.