Details of the newly submitted application have not been made public, but it is widely thought that the company may be seeking approval for the drug to be sold without a prescription to women who are 18 years of age or over.
An application for Plan B to be made available to women over the age of 16 is currently under review with the FDA, but it is believed that the company has raised the proposed age limit in an attempt to win approval.
The company originally wanted to sell the drug over-the-counter without an age restriction; however this application received a ‘not approvable’ letter from the FDA in May 2004. Plan B is currently available in the US with a prescription.
The issue of contraception, particularly of the ‘morning after’ variety, is a contentious one in the US, where it meets with considerable resistance from conservative elements of the population.