Barr Pharmaceuticals has announced that its subsidiary, Duramed Pharmaceuticals has submitted a formal response in support of its Supplemental New Drug Application (sNDA) for an Over-the-Counter (OTC) Plan B(R) emergency contraceptive product.
The submission is in response to the Not Approvable Letter that it received for its application from the U.S. Food and Drug Administration back in May. In its formal response to the Not Approvable letter, the Company has submitted to the FDA information supporting the marketing of Plan B as a prescription-only product for women 15 years of age and younger and a nonprescription product for women 16 years of age and older. Duramed currently markets Plan B as a prescription only product.
Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89 percent after a single act of unprotected sex. Plan B is most effective when taken in the first 24 hours after intercourse. Effectiveness declines as the interval between intercourse and the start of treatment increases. The major side effect associated with Plan B is nausea.
Emergency contraception is currently available in 101 countries, 33 of which do not require a prescription. Emergency contraception is currently available in a limited number of pharmacies without an advance prescription from a physician or healthcare provider in six U.S. states (Alaska, California, Hawaii, Maine, New Mexico and Washington).
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B regimen consisting of the emergency use of two progestin pills. POPs are not recommended for use in the following conditions: known or suspected pregnancy; hypersensitivity to any component of the product; and, undiagnosed abnormal genital bleeding.