NDAORAL-28TABLET
Approved
Oct 1967
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
OVULEN-28 (ethynodiol diacetate; mestranol) by Pfizer is clinical pharmacology combination oral contraceptives act primarily by suppression of gonadotropins. Approved for pregnancy in women. First approved in 1967.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OVULEN-28 is a combination oral contraceptive containing ethynodiol diacetate and mestranol, approved by Pfizer in 1967. It prevents pregnancy by suppressing gonadotropins and inhibiting ovulation, while also altering cervical mucus and endometrial tissue to reduce conception likelihood. The 28-day formulation includes 21 active tablets and 7 placebo tablets for convenient monthly cycling.
LOE Approaching
Legacy product in late-stage lifecycle with minimal commercial investment; team focus likely on managed decline and generic transition strategy.
Mechanism of Action
CLINICAL PHARMACOLOGY Combination oral contraceptives act primarily by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations in the genital tract, including changes in the cervical mucus (which increase the difficulty of sperm…
Indications (1)
Career Relevance
OVULEN-28 offers minimal career growth but stable regulatory and compliance roles. This is a heritage brand in post-peak lifecycle, appropriate for professionals seeking lower-intensity product experience or transitional roles before assignment to growth-stage assets.
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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.