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Pfizer requests for OTC status for Viagra in the U.K.

Apr 11, 2017

Pfizer requests for OTC status for Viagra in the U.K.

Almost nine years post the last try to make the company’s epic erectile dysfunction treatment to be available without the need of prescription, Pfizer is yet again having another green signal.

The company is looking forward to reconstruct Viagra (sildenafil) as a pharmacy medicine in the U.K., nearly after a decade of its initial request to make Viagra an OTC drug.

The UK supervisory body, the Medicine and Healthcare products Regulatory Agency (MHRA) has started to review Pfizer’s application to let Viagra 50mg be made available at any pharmacy without requiring any prescription.

On Tuesday, MHRA started a public discussion attempt pertaining to the reclassification and will gather all the feedbacks until April 18. In 2008, when European Medicines Agency noticed a few concerns, Pfizer adjourned its request application to change Viagra from prescription to OTC in the European Union.

A spokesperson from Pfizer through email said that the company is in talks with MHRA and estimates that the regulatory board to review and continue throughout the forthcoming months. He said, "Pfizer is committed to patient safety, and to ensuring that non-prescription sildenafil is supplied in a way that supports patient safety and improves patient health. Pharmacists are well placed to provide men with helpful and appropriate guidance to manage their erectile dysfunction, and should refer men to a doctor if they believe further investigation is required."

If the request gets an approval, Pfizer has strategized plans to prolong to market the drug as a prescription-only treatment under the brand name Viagra, and then they will render pharmacists with desired training on distributing at a 50mg dosage.

Dr Berkeley Phillips, Pfizer’s UK medical director says, “The availability of pharmacist-supplied, non-prescription sildenafil could offer men a new and additional way to access a legitimate, long established, and well-studied treatment for erectile dysfunction.

“This could have further benefits as the condition may be an early warning sign of a more serious underlying condition, such as heart disease4, which may otherwise go undetected.”

If approved, the reclassified pharmacy drug will be named by its generic name, sildenafil, however the pill will continue to look similar to the diamond shaped blue along with the company name ‘Pfizer’ incised on the sides. According to MHRA legal charge, the branded drug Viagra that comes in three variants, i.e., 25mg, 50mg, and 100mg will continue to be commercialized separately as a prescription-only treatment for erectile dysfunction.

Descending from $1.3 billion in 2015, Viagra made sales of $1.18 billion in 2016 on a global level. On being asked about the possibility for OTC Viagra in the United States, Pfizer spokesperson said the company is assessing several prescription drugs for a likely switch to OTC status.

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