iPLEDGE restrictions

November 1, 2007

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National report - The Food and Drug Administration (FDA) has loosened some restrictions in the federal iPLEDGE isotretinoin registry program to make it less cumbersome for doctors to prescribe Accutane and the drug's generic equivalents.

The revisions extend the number of days granted to patients to fill their prescriptions, and eliminate a 23-day waiting period when prescriptions aren't filled on time.

The agency eliminated the 23-day lockout for females of childbearing potential, with the exception of the first prescription to be filled, according to an FDA statement.

The changes were proposed by Roche Holding AG, makers of Accutane, and three manufacturers of generic isotretinoin at a joint meeting of the FDA's Dermatologic and Ophthalmic Drugs and Drug Safety and Risk Management advisory committees, according to an FDA statement.

Label changes apply to both brand-name and generic versions of the drug, and are to go into effect Dec. 2. Barr Laboratories, Genpharm/Mylan Pharmaceuticals and Ranbaxy Laboratories manufacture generic versions.

Roche says the label changes are intended to enhance the flexibility of the iPLEDGE program, reduce interruptions in treatment and reduce the burden on patients, prescribers and pharmacies, thereby making the program more consistent with the way prescribers function, according to the FDA statement.

Peer-reviewed journal debuts for derm Pas

San Antonio - The Society of Dermatology Physician Assistants (SDPA) has launched the first peer-reviewed clinical journal for physician assistants in dermatology.

The quarterly Journal of Dermatology for Physician Assistants will include articles on clinical, surgical, cosmetic and professional development as well as articles focused on dermatology CME credit, according to society President Robert Higham, M.P.A.S., P.A.-C.

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