Currently in the US, women over 17 can buy the high-dose birth control pill over the counter, but women younger than 17 need a prescription.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has applied to the US Food and Drug Administration (FDA) to grant its Plan B One-Step morning-after pill full nonprescription status for women of all ages, US media reports.
Currently in the US, women over 17 can buy the high-dose birth control pill over the counter, but women younger than 17 need a prescription.
Teva USA senior director of corporate communications Denise Bradley said, "Our 2003 Plan B application and our current application for Plan B One-Step is seeking over-the-counter status for the product based on data that demonstrate the product meets the scientific criteria that FDA has established for over the counter products. Label comprehension and safety data show that all women are able to safely and effectively take this product. It is not typical for any women's health product to have age restrictions."
FDA spokesman Jeff Ventura said, "The application will go through the normal FDA review process. It will be evaluated against the same scientific and regulatory criteria as all other over-the-counter switch applications."
Published by Globes [online], Israel business news - www.globes-online.com - on February 27, 2011
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