HEALTH

Pfizer drops application to switch Viagra to OTC

BY Alaric DeArment

NEW YORK Pfizer has withdrawn its application to switch 50 mg Viagra tablets from prescription to OTC in the European Union, the drug maker announced Thursday.

The company said it considers Viagra a suitable candidate for OTC availability and meets the European Commission’s criteria for OTC switches.

However, in a letter to the European Medicines Agency, Pfizer said it would withdraw the application to fully consider comments from the EMEA’s Committee for Medicinal Products for Human Use, recognizing that there were concerns regarding the proposed supply of the tablets without prescription in the EU. Pfizer said the withdrawal would allow evaluation of further information and additional data that may be required to allow any future assessments.

“Viagra has a proven safety profile that has been well-established in extensive post-marketing studies and in more than 120 clinical trials,” Pfizer vice president of medical and regulatory affairs Rory O’Connor said in a statement. “We will continue to work with regulators in Europe to improve the availability of our medicines to patients and physicians and the benefits they get from our therapies.”

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
HEALTH

NFL players identify supplement as source of positive steroids test

BY Michael Johnsen

NEW YORK A trio of National Football League players have fingered the dietary supplement industry in their defense against a positive test for the banned prescription diuretic bumetanide, claiming that the ingredient was found in the Nikki Haskell’s StarCaps weight-loss supplement, which is sold in specialty outlets GNC, Vitamin Shoppe and Great Earth Vitamin Stores according to the StarCaps Web site.

The ingredient is not listed among the dietary supplement ingredients for StarCaps; and there appears to have been no warning letters to date issued by the Food and Drug Administration citing StarCaps for distributing a prescription drug in a nonprescription setting. There also appears to be no action taken by the Federal Trade Commission regarding the company.

However, David Cornwell, attorney for New Orleans Saints players Deuce McAllister, Will Smith and Charles Grant, in a statement issued Wednesday suggested that the NFL had prior knowledge as to StarCaps containing bumetanide. “John Lombardo, the Steroid Policy’s Independent Administrator, testified that he learned in late 2006 that StarCaps contain the diuretic, bumetanide. Dr. Lombardo did not inform NFL players because he feared that a specific warning regarding StarCaps could be used as a defense to alleged violations of the Steroid Policy that involved weight reduction products other than StarCaps,” Cornwell said, as reported on ESPN.com. “Lombardo’s failure to disclose what he knew about StarCaps may have exposed NFL players to the significant health risks associated with the unintentional ingestion of diuretics. If Lombardo had notified NFL players that StarCaps contained bumetanide, Will, Deuce and Charles would have never used the product to lose weight.”

On StarCaps’ Web site, the company has reported it has suspended shipping of StarCaps pending an investigation into its own product. “We’ve received notice of a problem with an NFL player,” the company said. “We have referred the matter to our counsel and are taking all necessary steps to ensure that our customers receive product that is safe and effective.”

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
HEALTH

J&J pulls online Motrin ad after negative social networking site reactions

BY Jenna Duncan

LANGHORNE, Pa. Health and personal care giant Johnson & Johnson was urged to take down an online video ad for Motrin brand ibuprophen geared towards mothers who suffer pain from carrying babies during the day after some Internet users responded that the ad was insensitive, reports said.

The video interstitial featured a barrage of moving text and line art images which showed back, neck and shoulder pain related to carrying babies in slings and packs. Some viewers took issue with the use of language that suggested carrying a baby all day was “in fashion,” as well as other statements related to motherhood and pain.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?