Oxytrol For Women Gets OTC Green Light As Rare First-In-Class Switch
This article was originally published in The Tan Sheet
Executive Summary
Despite concerns raised by the Nonprescription Drug Advisory Committee in November, FDA approves Merck’s overactive bladder drug Oxytrol for Women for OTC use. The company plans a launch in the fall.
You may also be interested in...
Top OTC Stories 2013: Switch, Consumer Business Divestment Plans
The most-read OTC sector stories in “The Tan Sheet” during 2013 include Sanofi’s switch of Nasacort AQ 24HR, an interview with the former director of FDA’s Division of Nonprescription Clinical Evaluation, and Merck and Novartis each pondering the sale of its consumer health unit.
Top OTC Stories 2013: Switch, Consumer Business Divestment Plans
The most-read OTC sector stories in “The Tan Sheet” during 2013 include Sanofi’s switch of Nasacort AQ 24HR, an interview with the former director of FDA’s Division of Nonprescription Clinical Evaluation, and Merck and Novartis each pondering the sale of its consumer health unit.
Oxytrol Switch Should Hinge On Symptom ID, Not Diagnosis – Merck Consultant
Merck’s proposed Rx-to-OTC switch of Oxytrol for Women is about identifying symptoms of overactive bladder, not diagnosing the condition, says Eric Brass, former chair of FDA’s Nonprescription Drugs Advisory Committee. Several NDAC members Nov. 9 insisted OAB should be diagnosed before treatment.