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)

Active Pharmaceutical Ingredient (API):
  • 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).

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.

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