Petros Pharmaceuticals Announces Two Upcoming FDA Meetings to Review Progress and Path Forward for STENDRA(R) (avanafil) Rx-to-OTC Switch [Yahoo! Finance]
Petros Pharmaceuticals, Inc. (PTPI)
Company Research
Source: Yahoo! Finance
NEW YORK, NY / ACCESSWIRE / January 24, 2024 Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has scheduled two meetings with the U.S. Food and Drug Administration (FDA) to review the Company's progress and path forward in developing STENDRA as the first PDE-5 inhibitor approved as an over-the-counter medication for erectile dysfunction. (Please see Important Safety Information below.) The Company has scheduled a Type C meeting with the FDA on March 26, 2024, to review the Company's developing digital app for use under the FDA's Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) proposed rule.[1] Primary topics of the meeting are expected to include how to continue the development of the app, protocols for upcoming studies, including the Summative Human Factors Study. In addition, the FDA has requested a listen-only me
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PTPI
News
- Petros Pharmaceuticals announces online distribution for lead ED product with Lemonaid Health [Yahoo! Finance]Yahoo! Finance
- Petros Pharmaceuticals Expands Online Distribution for Prescription STENDRA(R) (avanafil) Through New Agreement with Lemonaid Health [Yahoo! Finance]Yahoo! Finance
- Petros Pharmaceuticals Expands Online Distribution for Prescription STENDRA(R) (avanafil) Through New Agreement with Lemonaid HealthAccesswire
- Petros Pharmaceuticals Receives Positive Response from FDA Following Recent Demonstration of Technology Component in Pursuit of OTC Status for STENDRA(R) (avanafil) Accesswire
- Petros Pharmaceuticals Reports Positive Results in an Initial Cohort Two-Arm Self-Selection (Phase 2-Equivalent) Study for STENDRA(R) (avanafil) as it Pursues OTC StatusAccesswire
PTPI
Sec Filings
- 4/1/24 - Form 10-K
- 3/22/24 - Form 8-K
- 2/14/24 - Form SC
- PTPI's page on the SEC website