Barr to resubmit contraceptive for FDA approval

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Barr Pharmaceuticals Inc. aims to resubmit within two weeks a request for approval of its morning-after contraceptive pill for over-the-counter use, 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 to women ages 16 or older.

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

"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.

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