FDA Announces New Guidance Documents on Drug Products

The Food and Drug Administration announced the availability of new guidance documents on drug products. The draft guidances provide "product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)," FDA said. The new guidance documents cover Acarbose; Acetaminophen, Aspirin, Caffeine; Acetaminophen, Butalbital, Caffeine, Codeine phosphate; Acitretin; Amoxicillin (multiple reference listed drugs); Amoxicillin, Clavulanate Potassium; Aspirin, Butalbital, Caffeine (multiple reference listed drugs); Aspirin, Butalbital, Caffeine, Codeine Phosphate; Atenolol; Atenolol and Chlorthalidone; Cetirizine HCl; Chlorthalidone; Citalopram HBr; Citalopram hydrobromide; Clarithromycin; Clindamycin HCl; Clomiphene Citrate; Clonazepam; Clozapine; Cyclobenzaprine HCL; Cycloserine; Dapsone; Desipramine HCl; Desmopressin Acetate; Diflunisal; Diphenhydramine HCl; Dipyridamole; Disulfiram; Donepezil HCl; Doxazosin mesylate; Doxepin HCl; Doxercalciferol; Eprosartan Mesylate; Ethambutol HCl; Hydrochlorothiazide, Losartan Potassium; Hydrochlorothiazide, Triamterene; Hydrochlorothiazide, Valsartan; Hydrocodone bitartrate, Ibuprofen; Hydrocortisone; Hydromorphone HCl; Selegiline hydrochloride; Sotalol HCl; Tenofovir Disoproxil Fumarate; Tiagabine HCl; Valproic acid; and Verapamil HCl.