NDAORALTABLET, ORALLY DISINTEGRATING
Approved
Jul 2024
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
5/8 — Partial
FEMLYV (norethindrone acetate/ethinyl estradiol) by Millicent Pharma is ovulation. Approved for pregnancy () limitations of use the efficacy in females of reproductive potential with a body mass index of more than 35 kg/m has not been evaluated (. First approved in 2024.
Drug data last refreshed 2h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FEMLYV is an oral contraceptive tablet combining norethindrone acetate and ethinyl estradiol, approved in July 2024 as an orally disintegrating formulation. It prevents pregnancy through ovulation suppression and is indicated for females of reproductive potential, though efficacy has not been evaluated in those with BMI >35 kg/m². The product represents a novel delivery format in the combined oral contraceptive market.
Growth14.9 years to LOE
Early-stage growth product with no current Part D data; commercial infrastructure and sales team buildout are likely priorities for Millicent Pharma.
Mechanism of Action
ovulation.
Career Relevance
FEMLYV is a newly approved product in a mature therapeutic area, offering early-career opportunities in brand launch and commercial scaling but limited clinical development roles. Career progression will depend heavily on Millicent Pharma's market share success and ability to differentiate the orally disintegrating formulation in a competitive generics-dominated landscape.
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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.