FDA releases 48 new and revised bioequivalence guidelines for generics

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The US Food and Drug Administration (FDA) has released 44 new draft guidance documents and four revisions to guidance documents on bioequivalence requirements for the development of generics containing 46 different active ingredients. 

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The US Food and Drug Administration (FDA) has released 44 new draft guidance documents and four revisions to guidance documents on bioequivalence requirements for the development of generics containing 46 different active ingredients.

The new draft bioequivalence guidance documents cover generics of HIV medicines Triumeq (abacavir/dolutegravir/lamivudine) and Tivicay (dolutegravir), pain killer aspirin, asthma treatment DuoResp Spiromax (budesonide/formoterol fumarate dihydrate) and acid relux treatment Nexium (omeprazole), among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of high cholesterol treatment Questran (cholestyramine), acne treatment Doryx (doxycycline), angina treatment Efient (prasugrel) and anti-convulsive medication Gabitril (tiagabine), see Table 2.

 Table 1: FDA new draft bioequivalence guidance documents

Active ingredient Route of administration Dosage form Link
Abacavir sulfate/dolutegravir/ lamivudine Oral Tablet Click here
Afatinib Oral Tablet Click here
Alendronate Oral Effervescent tablet Click here
Aspirin Oral Capsule Click here
Azelastine/fluticasone propionate Nasal Metered spray Click here
Budesonide/formoterol Inhalation Metered aerosol Click here
Calcium carbonate/ famotidine/ magnesium hydroxide Oral Chewable tablet Click here
Canagliflozin/ metformin Oral Tablet Click here
Cyclophosphamide Oral Capsule Click here
Cyproheptadine Oral Tablet Click here
Dabrafenib Oral Capsule Click here
Dapagliflozin propanediol Oral Tablet Click here
Dexbrompheniramine maleate/ pseudoephedrine sulphate Oral Capsule Click here
Dolutegravir Oral Tablet Click here
Donepezil/memantine Oral ER tablet Click here
Doxycycline Oral Tablet Click here
Droxidopa Oral Capsule Click here
Eliglustat Oral Capsule Click here
Empagliflozin Oral Tablet Click here
Emtricitabine/tenofovir Oral Tablet Click here
Enzalutamide Oral Capsule Click here
Fentanyl Sublingual Spray Click here
Indomethacin Oral Capsule Click here
Lanthanum carbonate Oral Powder Click here
Levalbuterol tartrate Inhalation Metered aerosol Click here
Levomilnacipran Oral ER capsule Click here
Macitentan Oral Tablet Click here
Methazolamide Oral Tablet Click here
Miglitol Oral Tablet Click here
Naloxegol oxalate Oral Tablet Click here
Naproxen sodium Oral Capsule Click here
Nitroglycerin Transdermal Ointment Click here
Omeprazole Oral Powder suspension Click here
Oxybutynin Transdermal ER film Click here
Oxybutynin Transdermal Metered gel Click here
Oxycodone Oral Capsule Click here
Primaquine Oral Tablet Click here
Sildenafil Oral Suspension Click here
Simeprevir Oral Capsule Click here
Sofosbuvir Oral Tablet Click here
Tolcapone Oral Tablet Click here
Vemurafenib Oral Tablet Click here
Vismodegib Oral Capsule Click here
Vortioxetine hydrobromide Oral Tablet Click here

ER: extended release; FDA: US Food and Drug Administration.
 
Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient Route of administration Dosage form Link
Cholestyramine Oral Powder Click here
Doxycycline hyclate Oral DR tablet Click here
Prasugrel Oral Tablet Click here
Tiagabine Oral Tablet Click here

DR: delayed release; FDA: US Food and Drug Administration.

The draft guidance documents recommend what in vivo and in vitro studies generics companies should carry out in order to demonstrate bioequivalence. The number of studies, the population to be studied, blood sampling time points and analytes to be measured in blood samples are also detailed in the draft guidance documents.

In total the FDA now has 1,321 product-specific guidelines with bioequivalence study recommendations. The agency also has an overarching guidance document on bioequivalence recommendations for specific products [1].

Comments on the draft guidance documents can be posted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. This can be done via the website www.regulations.gov or written comments can be mailed to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 21]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: US FDA

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