Petitions Denied For ‘Pharmacist Category’ Nonprescription Viagra, Lipitor, Chantix
This article was originally published in The Tan Sheet
The petitioner offers no evidence to support establishing a “Pharmacists Category of Drugs Behind the Counter” status for nonprescription sales with continued Rx distribution of Viagra, Lipitor, Narcan and Chantix, CDER Director Woodcock says in rejecting a petition on each drug.
You may also be interested in...
Norway's move to encourage more innovative Rx-to-OTC switches has begun to bear fruit with the recent reclassification of Pfizer's Viagra. The country's decision to introduce a new non-prescription drug category to promote switching can be used as a model for securing a new wave of more complex switches elsewhere around the world.
Pfizer has taken the first steps towards turning its Viagra erectile dysfunction treatment into a pan-European OTC brand by taking advantage of Norway's new "non-prescription medicines with guidance" category to secure the Rx-to-OTC switch of the product. Norway will be the second European market where Viagra is available OTC after the UK switched the drug in 2017.
When firms suggest submitting switch NDAs for “something that would be worth engaging on, we’re not going to tell you no,” says FDA nonprescription drug program chief Theresa Michele.