NDAORALTABLET
Approved
Nov 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
FEMCON FE (ethinyl estradiol; norethindrone) by Viatris (2) is clinical pharmacology combination oral contraceptives act by suppression of gonadotropins. Approved for pregnancy in women. First approved in 2003.
Drug data last refreshed 2d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FEMCON FE is a combination oral contraceptive containing ethinyl estradiol 35 mcg and norethindrone 0.4 mg, indicated for prevention of pregnancy in women. It works by suppressing gonadotropins to inhibit ovulation, while also altering cervical mucus and endometrial tissue to reduce implantation likelihood. The product includes iron supplementation in the reminder tablets to support women's health during the hormone-free interval.
LOE Approaching
As a mature contraceptive approaching loss of exclusivity with minimal recent spending data, FEMCON FE faces significant commercial pressure; career growth is limited and teams are likely consolidating or transitioning to newer formulations.
Mechanism of Action
CLINICAL PHARMACOLOGY Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.