Drugs / Norgestrel
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | OPILL | — | 2023-07-13 | fda.gov ↗ |
| Filed | US (FDA) | Opill | contraception | 2022-07-11 | “has submitted its application to the United States Food and Drug Administration (FDA) for the first-ever over-the-counter (OTC) birth control pill” perrigo.com ↗ |
| Approved | US (FDA) | OVRAL | — | 1968-04-16 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT03585712 | Jul 2018 → Apr 2020 | — | HRA Pharma | Completed | Missed primary |
| Phase 2 | NCT00033358 | Feb 2002 → Oct 2007 | endometrial cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04112095 | Sep 2019 → Aug 2021 | — | HRA Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03559010 | Apr → Sep 2018 | — | HRA Pharma | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-07-13 | Perrigo Company | Regulatory Perrigo Announces U.S. FDA Approval for Opill® OTC Daily Oral Contraceptive perrigo.com ↗
Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, announced today that the U.S. Food and Drug Administration (FDA) approved Opill ® , a progestin-only daily oral contraceptive, for over-the-counter (OTC) use for all ages. |
| 2023-05-10 | Perrigo Company | Regulatory FDA Joint Advisory Committee Votes in Favor of Perrigo's Opill® Daily Oral Contraceptive for OTC Use perrigo.com ↗
Today's vote to recommend a switch of Opill ® to OTC is a new, groundbreaking chapter in reproductive health. |
| 2022-07-11 | Perrigo Company | Regulatory Perrigo's HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill perrigo.com ↗
The company has applied for an Rx-to-OTC switch for Opill ® , a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-07-13 | Perrigo Company | Perrigo Announces U.S. FDA Approval for Opill® OTC Daily Oral Contraceptive perrigo.com ↗ |
| 2023-05-10 | Perrigo Company | FDA Joint Advisory Committee Votes in Favor of Perrigo's Opill® Daily Oral Contraceptive for OTC Use perrigo.com ↗ |
| 2022-07-11 | Perrigo Company | Perrigo's HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill perrigo.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Norgestrel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03559010 ↗ |
| Known as | Norgestrel 75 mcg | “Norgestrel 75 mcg” NCT03585712 ↗ |
| Known as | Opill | “this prospective, multicenter, randomized, crossover study assesses the effect of norgestrel 75 mcg (Opill) on cervical mucus and ovarian activity” PMID 33970869 ↗ Jun 2021 |
| Route | Oral | “taken orally” NCT03559010 ↗ |