Barr refiles morning-after pill bid with US FDA
Posted on: Friday, 18 August 2006, 16:02 CDT
WASHINGTON (Reuters) - Barr Pharmaceuticals Inc. has refiled its application to sell the Plan B "morning-after" pill without a prescription, the company and U.S. regulators said on Friday.
Barr spokeswoman Carol Cox and FDA spokeswoman Susan Bro both said the company had resubmitted the Plan B application but declined to comment on the contents.
Last month, the agency urged Barr to reapply to sell the emergency contraceptive without a prescription to women 18 and older.
The company originally had sought approval to sell Plan B over the counter without an age limit but later revised the request to 16 and older at the FDA's suggestion. The drug can prevent pregnancy if taken within 72 hours of sexual intercourse.
The bid to ease access has stalled at the FDA for years amid fierce lobbying by supporters and opponents.
Backers say wider availability could reduce the number of abortions, while opponents argue it may increase promiscuity, particularly among teenagers.
Barr shares fell 24 cents to close at $57.80 on the New York Stock Exchange on Friday.
Source: REUTERS
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