August 09, 2006
Barr to resubmit Plan B application
Barr Pharmaceuticals will resubmit a request to sell its morning-after contraceptive, Plan B, without a prescription, the company said after meeting with FDA officials yesterday.
Barr spokeswoman Carol Cox told Reuters yesterday the company intends to have a submission back into the FDA in the next two weeks.
Last week, in a letter sent to Barr, the FDA said it would re-examine sales of Plan B without a prescription, proposing that pills would be kept behind pharmacy counters and women would need to ask for them. Women younger than 18 still would need a prescription. In the letter, the FDA said it hoped to wrap up Barr's application, which has lingered at the agency since 2003, within weeks.
Cox and FDA spokeswoman Susan Bro described yesterday’s meeting as “productive.”