Press Release: Opella reaches study milestone for Cialis - Sanofi
Jan 21, 2006 · Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) to support the …
Sanofi's Opella: FDA Lifts Clinical Hold On OTC Cialis Trial
Jan 21, 2025 · Sanofi's Consumer Healthcare division, Opella, announced that the U.S. Food and Drug Administration has lifted a clinical hold on its planned actual use trial (AUT). The trial is aimed at …
A Teaching Moment for Next Generation Rx-to-OTC Switch
Jun 22, 2022 · We propose at least three considerations that a sponsor seeking to switch a prescription drug to nonprescription status should consider. The first is objective verification of the consumer …
Sanofi reaches study milestone for Cialis | The Pharmaletter
Jan 21, 2025 · This decision allows for the initiation of the AUT and makes Cialis the first PDE-5 inhibitor to achieve this milestone.
FDA Puts Hold on Trial for Cialis OTC - Managed Healthcare Executive
Jun 2, 2022 · The FDA has put a clinical hold on a trial to support the Rx-to-OTC switch for Cialis (tadalafil) because of an issue related to the protocol design. Sanofi’s Actual Use Trial (AUT) has not …
FDA Lifts Clinical Hold on Sanofi’s Cialis Over-the-Counter Trial
Jan 22, 2025 · Sanofi initially planned to complete all registration approvals for Cialis after its patent expiration in 2017, aiming to relist it as an OTC drug. However, the FDA suspended the AUT for …
Actual Use Trial of Tadalafil 5 mg - ClinicalTrials.gov
Feb 24, 2025 · The purpose of this actual use trial (AUT) is to evaluate if participants can appropriately select and use the study product [Cialis over the counter (OTC)] using the labeling and the …
Opella's Cialis Milestone: A Step Towards Over-the-Counter Availability
Jan 21, 2025 · The US Food and Drug Administration (FDA) has lifted a clinical hold on the planned actual use trial (AUT) to support the switch of Cialis from a prescription to an OTC medicine. This …
Opella announces US FDA lifts clinical hold on its planned actual use ...
Jan 22, 2025 · Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) to support the …
Sanofi’s Opella reaches a new study milestone for Cialis
Jan 27, 2025 · Opella which is Sanofi’s Consumer Healthcare business has announced that the U.S. FDA has lifted a clinical hold on its planned actual use trial to support the switch of Cialis from a …