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Plan B seeks OTC status for women ages 16-plus
The emergency contraceptive (EC) Plan B may be available over the counter (OTC) to women ages 16 and older if the Food and Drug Administration (FDA) approves Pomona, NY-based Barr Pharmaceuticals’ revised request for OTC status.
Barr announced the submission of the addition to its Supplemental New Drug Application on July 22. The proposed change to seek dual marketing of the drug came after the FDA denied the company’s original request for OTC status. In a press release issued by the regulatory agency, the FDA says it based its action on the lack of data surrounding OTC use of Plan B among teens younger than age 16.
The new proposal would keep Plan B, a levonorgestrel-only EC, as a prescription drug to women ages 15 and younger and as an OTC product for women ages 16 and older.
According to a statement issued by the company, the FDA will have six months to review Barr’s application and make a determination. In the meantime, the company says it is focused on advancing awareness about Plan B among women and health care providers, as well as working toward increasing the number of states where Plan B is available in pharmacies without an advance prescription.