Plan B pill proposal amended
By ASSOCIATED PRESS
Published August 19, 2006
WASHINGTON - The manufacturer of the morning-after pill resubmitted an application Friday seeking federal approval to sell the emergency contraceptive without a prescription.
Barr Pharmaceuticals Inc. resubmitted the application to the Food and Drug Administration, company spokeswoman Carol Cox said. The company did not disclose the contents.
The FDA had asked Barr to amend its application to limit over-the-counter sales of the pills, called Plan B, to women 18 and older. The pills are now sold only by prescription in most states.
"Currently, we remain committed to an expeditious review," FDA spokeswoman Susan Bro said. Bro would not say when the FDA would decide on the application.
Barr originally applied to sell the pills to girls and women of all ages, but later amended its application to limit over-the-counter sales to those 16 and older.
The FDA said last month it would reconsider that application if the company further amended it to limit nonprescription sales to adult women. The agency also wants details on how pharmacists would enforce the age restrictions on those sales.
Plan B contains a high dose of a drug found in many regular birth control pills that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent.
[Last modified August 19, 2006, 01:38:53]
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