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Petros Pharmaceuticals (PTPI) FDA Events

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FDA Events for Petros Pharmaceuticals (PTPI)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Petros Pharmaceuticals (PTPI). Over the past two years, Petros Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as STENDRA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

STENDRA (avanafil) - FDA Regulatory Timeline and Events

STENDRA (avanafil) is a drug developed by Petros Pharmaceuticals for the following indication: Erectile dysfunction (ED). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Petros Pharmaceuticals FDA Events - Frequently Asked Questions

As of now, Petros Pharmaceuticals (PTPI) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Petros Pharmaceuticals (PTPI) has reported FDA regulatory activity for STENDRA (avanafil).

The most recent FDA-related event for Petros Pharmaceuticals occurred on September 11, 2024, involving STENDRA (avanafil). The update was categorized as "Results," with the company reporting: "Petros Pharmaceuticals announced results of an initial study to determine consumer comprehension of the messaging in its App Technology ("App Comp"), which has unique differences from the current Drug Facts Label ("DFL"). Of the 31 objectives, 29 scored >90% comprehension Point Estimate ("PE"), 30 scored >86.7% comprehension PE, and all scored >80% comprehension PE. 21 scored 100% comprehension PE."

Currently, Petros Pharmaceuticals has one therapy (STENDRA (avanafil)) targeting the following condition: Erectile dysfunction (ED).

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:PTPI) was last updated on 7/11/2025 by MarketBeat.com Staff
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