FDA Announces New and Revised Draft Guidance Documents on Drug Products
The Food and Drug Administration announced the availability of new and revised draft guidances on drug products, it said (here). The draft guidances (here) provide "product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated…
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new drug applications (ANDAs)," FDA said. New draft guidances cover Aspirin; Aspirin (omeprazole); Brexpiprazole; Brivaracetam; Cefdinir; Clocortolone pivalate; Cyanocobalamin; Dasabuvir sodium; Ombitasvir; Paritaprevir; Ritonavir; Dextroamphetamine sulfate; Diclofenac sodium; Fluphenazine hydrochloride; Gentamicin sulfate; Glycopyrrolate; Obeticholic acid; Silver sulfadiazine; Tenofovir alafenamide fumarate; Tiopronin; Tipiracil hydrochloride; Trifluridine; Triamcinolone acetonide (multiple reference listed drugs); and Uridine triacetate. FDA has revised its draft guidances on Brimonidine tartrate; Dabigatran etexilate mesylate; Dorzolamide hydrochloride; Gefitinib Latanoprost; Methoxsalen; Metoprolol tartrate; Minocycline HCl (multiple reference listed drugs); Minoxidil; Pimozide; Propafenone hydrochloride; and Tetrabenazine.