- Safety & Recalls
- Regulatory Updates
- Drug Coverage
- COPD
- Cardiovascular
- Obstetrics-Gynecology & Women's Health
- Ophthalmology
- Clinical Pharmacology
- Pediatrics
- Urology
- Pharmacy
- Idiopathic Pulmonary Fibrosis
- Diabetes and Endocrinology
- Allergy, Immunology, and ENT
- Musculoskeletal/Rheumatology
- Respiratory
- Psychiatry and Behavioral Health
- Dermatology
- Oncology
FDA Postpones Advisory Committee Meeting for OTC Birth Control
If approved, Perrigo’s Opill could be the first-ever nonprescription birth control pill.
The FDA has postponed the joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and the Urologic Drugs Advisory Committee to discuss Perrigo’s application for the nonprescription oral contraceptive. The meeting was originally scheduled for Nov. 18, 2022, to discuss the Opill Rx-to-OTC switch. The date of the new meeting has not yet been determined.
The FDA has postponed the meeting in order to review additional information the agency requested. The agency has also extended the Prescription Drug User Fee Act (PDUFA) date for Opill by 90 days.
Opill is a progestin-only daily birth control pill, which is also referred to as a mini pill or non-estrogen pill. While progestin-only birth control pills can still increase your risk of blood clots and stroke, they’re generally seen as safer for some women, including those who smoke, have high blood pressure or those at risk for blood clots.
HRA Pharma, a Perrigo company, had submitted its application in July 2022.
Related: FDA Schedules Advisory Committee Meeting for Nonprescription Birth Control
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
