FDA Finalizes 46 Bioequivalence Guidances

Regulatory NewsRegulatory News
| 04 August 2017 | By Michael Mezher 

In its continued push to support the development of generic drugs, the US Food and Drug Administration (FDA) on Friday finalized 46 product-specific bioequivalence guidances.

The guidances, which lay out FDA's expectations for the studies that should be done to demonstrate that a generic drug is bioequivalent to its reference product, give specific recommendations for what analytes to measure, what dissolution test methods and sampling times

Some of the guidances also specify the testing that can be done in order to obtain a waiver for in vivo testing, though for some products, such as valporic acid, FDA says in vivo tests should be done.

While the agency has released several batches of new and revised draft bioequivalence guidances since 2016, this is the first time the agency has finalized any bioequivalence guidances since September 2015.

Among the latest final guidances are recommendations for Gilead's hepatitis B and HIV drug Viread (tenofovir disoproxil fumarate), multiple formulations of the antibiotic drug amoxicillin and the anti-seizure drug clonazepam.

Final Product-Specific Guidances
Acetaminophen; Aspirin, Caffeine
Acetaminophen; Butalbital; Caffeine; Codeine phosphate
Amoxicillin (multiple reference listed drugs)
Amoxicillin; Clavulanate potassium
Aspirin; Butalbital; Caffeine (multiple reference listed drugs)
Aspirin; Butalbital; Caffeine; Codeine Phosphate
Atenolol and Chlorthalidone
Cetirizine HCl
Citalopram HBr
Citalopram hydrobromide
Clindamycin HCl
Clomiphene Citrate
Cyclobenzaprine HCL
Desipramine HCl
Desmopressin Acetate
Diphenhydramine HCl
Donepezil HCl
Doxazosin mesylate
Doxepin HCl
Eprosartan Mesylate
Ethambutol HCl
Hydrochlorothiazide; Losartan Potassium
Hydrochlorothiazide; Triamterene
Hydrochlorothiazide; Valsartan
Hydrocodone bitartrate; Ibuprofen
Hydromorphone HCl
Selegiline hydrochloride
Sotalol HCl
Tenofovir Disoproxil Fumarate
Tiagabine HCl
Valproic acid
Verapamil HCl


FDA, Federal Register Notice


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