NEW YORK The approval of Watson Pharmaceutical’s ANDA for levonorgestrel tablets, otherwise known as the emergency contraceptive Plan B, marks the first time a generic company gained prescription-only approval for one month, even as it awaits nonprescription approval for the same drug a few months down the line.
Of course, it’s fitting, as Plan B is the only medicine available as both a prescription and nonprescription remedy at the same strength and for the same indication, the only distinguishing factor being the age of the patient.
Watson, citing IMS Health data, noted that Plan B generated $123 million for the 12 months ended March 2009, 10% of which consisted of Plan B prescriptions for use in women younger than 18. Watson will be launching the product under the brand name Next Choice.
The Watson product may be dispensed without a prescription in nine states, however, as those states still allow a pharmacist to dispense the emergency contraceptive with a standing prescription from a local doctor.
The Food and Drug Administration stated that an OTC approval of generic Plan B won’t be forthcoming until after Aug. 12, which is when the OTC-switch exclusivity period expires. What will be interesting is whether or not this second approval will renew media interest in this hot-button medicine — Secretary of State Hillary Clinton and Sen. Patty Murray, D-Wash., refused to confirm FDA commissioner Andrew von Eschenbach in 2006 until the FDA made a decision around switching Plan B.
And while there may not be any political fallout with a Democratic House and Hill, the emergency contraceptive has long raised an issue around patient access to convenient and effective medicines, versus the right of a pharmacist to refuse to dispense that medicine out of conscientious objection.