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Viatris (VTRS)
NASDAQ:VTRS
Phentolamine Ophthalmic Solution 0.75%, A Non-Selective Alpha-1 And Alpha-2 Adrenergic Antagonist
Mesopic Vision, Night Vision Loss
Phase III
Active Not Recruiting
Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances
Apr 01, 2024
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Mr-100A-01
Contraception
Phase III
Completed
Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles
Oct 20, 2021
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Viatris (VTRS) have in its pipeline
VTRS is currently developing the following drugs: Phentolamine Ophthalmic Solution 0.75%, A Non-Selective Alpha-1 And Alpha-2 Adrenergic Antagonist, Mr-100A-01. These drug candidates are in various stages of clinical development as the company works toward FDA approval.