The FDA has published 60 product-specific recommendations outlining its attitudes and expectations for developing therapeutically equivalent generic medicines.
The FDA has published 60 product-specific recommendations outlining its attitudes and expectations for developing therapeutically equivalent generic medicines. The documents explain the studies and study characteristics needed when submitting an Abbreviated New Drug Application for those products, as well as the bioequivalence standards each product must meet.
The medications include ticagrelor (Brilinta); lorcaserin (Belviq); ibrutinib (Imbruvica); emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate (Complera); avanafil (Stendra); azilsartan kamedoxomil and chlorthalidone (Edarbyclor); ivacaftor (Kalydeco); and vigabatrin (Sabril). Many of the prescription products have no generic version.
The list also includes several OTC medicines, including Aleve PM (Bayer), Imodium A-D (McNeil Consumer Healthcare), Advil Liqui- Gels (Pfizer), and Advil Allergy and Congestion Relief (Pfizer).
The FDA may alter the recommendations prior to creating final product- specific bioequivalence guidelines for each product. Comments should be submitted to the Division of Dockets Management under Docket FDA-2007-D-0369-0015. Electronic comments can be submitted through www.regulations .gov, and written comments can be sent to The Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, Maryland 20852.