InvestorsHub Logo
Replies to #32289 on Biotech Values
icon url

DewDiligence

08/08/06 3:19 PM

#32437 RE: DewDiligence #32289

Plan B for Plan B Nears Fruition

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20060808:MTFH12463_2...

>>
Barr to refile within 2 weeks

Tue Aug 8, 2006 2:25 PM ET

WASHINGTON, Aug 8 (Reuters) - Barr Pharmaceuticals Inc. <BRL> aims to resubmit within two weeks a request to sell its morning-after contraceptive pill without a prescription, the company said on Tuesday, following a meeting with U.S. Food and Drug Administration officials.

The comments come after FDA officials last week agreed to reopen discussions with the drugmaker over their bid to sell the Plan B drug over-the-counter to women ages 16 and older.

The agency has said it should be available without a doctor's order for women 18 and older but kept behind pharmacy counters.

Shares of the drugmaker were up 64 cents, or about 1.3 percent, at $51.29 in afternoon trading on the New York Stock Exchange.

"In response to FDA's comments, Barr intends to have a submission back into the FDA in the next two weeks," Barr spokeswoman Carol Cox told Reuters. She described the meeting with the FDA as "productive."

The company's bid to sell Plan B -- a set of two pills that can prevent pregnancy if taken within 72 hours of sexual intercourse -- without a doctor's note has stirred debate between supporters and critics who have lobbied the agency.

Democrats have also held up Senate confirmation for U.S. President George W. Bush's pick to lead the FDA, Acting FDA Commissioner Andrew von Eschenbach, until the agency makes a final decision on the plan.
<<