FDA's revised draft guidance on labeling for combined oral contraceptives removes dosing information on emergency use.

The first draft guidance, which was issued in June 2000, included information about certain brands of oral contraceptives that have been found to be safe and effective as emergency contraception.

A footnote from a chart in the original draft guidance listed products available for emergency use: Wyeth's Ovral and Lo/Ovral , Alesse and Triphasil ; Monarch's Nordette ; and Berlex' Levlen and Tri-Levlen . Labeling also listed the dosing regimens for each drug.

In comments on the first draft guidance, the Pharmaceutical Research & Manufacturers of America questioned FDA's inclusion of the information.

PhRMA questioned whether "off-label" indications should be included in labeling, and argued that it was inappropriate to include dosing recommendations for other manufacturers' products in another company's label.

Two products are approved by FDA for use as emergency contraception: Gynetics' Preven (levonorgestrel .25 mg/ethinyl estradiol .05 mg) and Barr's Plan B (levonorgestrel .75 mg).

An Rx-to-OTC switch application for Plan B is pending at FDA, and Barr recently acquired marketing rights for Preven from Gynetics.

After receiving the first set of comments on the guidance, FDA decided to reissue the draft, given the number of changes.

The ¹ revised draft guidance is scheduled for publication in the Federal Register March 5.

- Kate Rawson

FDA Oral Contraceptives Labeling Guidance Removes Mention Of Emergency Use

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