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FDA, Barr to meet next week on morning-after pill FDA, Barr to meet next week on morning-after pill

FDA, Barr to meet next week on morning-after pill

Drug NewsAug 03, 2006

Barr Pharmaceuticals Inc. and the U.S. Food and Drug Administration are scheduled to meet Tuesday to discuss the company’s bid to sell its morning-after contraceptive Plan B without a prescription, the agency said on Wednesday.

“The FDA and Barr Labs will meet on Tuesday in Washington, D.C. to discuss the letter we sent to the company” earlier this week, agency spokeswoman Susan Bro said.

In a letter to Barr on Monday, the FDA said it was taking a new look at proposed sales of Plan B—a set of two pills that can prevent pregnancy if taken within 72 hours of sexual intercourse—without a prescription.

The agency said the pills would be kept behind pharmacy counters and women would need to ask for them. Women younger than 18 still would need a prescription.

The FDA added that it hoped to wrap up Barr’s application, which has lingered at the agency since 2003, within weeks.

The pending decision over Plan B has been controversial, with supporters and critics alike relentlessly lobbying the FDA. It has also held up confirmation of an FDA chief.

Barr shares were up 95 cents or 1.9 percent at $50.16 in morning trade on the New York Stock Exchange.

Provided by ArmMed Media
Revision date: June 20, 2011
Last revised: by Tatiana Kuznetsova, D.M.D.

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