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FDA releases 53 new and revised bioequivalence guidelines for generics Posted 30/01/2015

On 12 December 2014, the US Food and Drug Administration (FDA) released 31 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

The new draft bioequivalence guidance documents cover generics of acne treatment Aczone (dapsone), antipsychotic medication Latuda, (lurasidone), chemotherapy drug Stivarga (regorafenib), HIV medicine Stribild (cobicistat/elvitegravir/emtricitabine/tenofovir), head lice treatment Ulesfia (benzyl alcohol) and arthritis treatment Xeljanz (tofacitinib), among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of high blood pressure treatment Bystolic (nebivolol), chemotherapy drug Doxil (doxorubicin), acne treatment Epiduo (adapalene/benzoyl peroxide) and Alzheimer’s drug Namenda (memantine), to name just a few, see Table 2.

Table 1: FDA new draft bioequivalence guidance documents

Active ingredient

Route of administration

Dosage form

Link

Acetaminophen/aspirin/caffeine

Oral

Tablet

Click here

Acetaminophen/butalbital/caffeine/codeine phosphate

Oral

Capsule

Click here

Acyclovir

Topical

Cream, 5%

Click here

Aripiprazole

Intramuscular

Injectable Suspension, Extended Release

Click here

Benzyl alcohol

Topical

Lotion

Click here

Betamethasone valerate

Topical

Foam, Aerosol

Click here

Bosutinib monohydrate

Oral

Tablet

Click here

Brimonidine tartrate/brinzolamide

Ophthalmic

Drops, Suspension

Click here

Budesonide

Oral

Tablet, Extended Release

Click here

Buprenorphine HCl/naloxone HCl

Oral

Tablet, Sublingual

Click here

Cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate

Oral

Tablet

Click here

Conjugated estrogens

Oral

Tablet

Click here

Dapsone

Topical

Gel, 5%

Click here

Darunavir ethanolate

Oral

Suspension

Click here

Ibuprofen sodium

Oral

Tablet

Click here

Levothyroxine sodium

Oral

Tablet

Click here

Lidocaine/prilocaine

Topical

Cream

Click here

Lomitapide mesylate

Oral

Capsule

Click here

Lurasidone HCl

Oral

Tablet

Click here

Methylphenidate HCl

Oral

Suspension,Extended Release

Click here

Metoprolol tartrate

Oral

Tablet

Click here

Nepafenac

Ophthalmic

Drops, Suspension 0.1%

Click here

Nepafenac

Ophthalmic

Drops, Suspension 0.3%

Click here

Posaconazole

Oral

Tablet, Delayed Release

Click here

Raltegravir potassium

Oral

Tablet, Chewable

Click here

Regorafenib

Oral

Tablet

Click here

Selegiline hydrochloride

Oral

Capsule

Click here

Testosterone

Transdermal

Film, Extended Release

Click here

Tofacitinib citrate

Oral

Tablet

Click here

Treprostinil diolamine

Oral

Tablet, Extended Release

Click here

Vandetanib

Oral

Tablet

Click here

 

Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient

Route of administration

Dosage form

Link

Adapalene

Topical

Lotion

Click here

Adapalene

Topical

Cream

Click here

Adapalene

Topical

Gel

Click here

Adapalene

Topical

Gel

Click here

Adapalene/benzoyl peroxide

Topical

Gel

Click here

Brimonidine tartrate

Ophthalmic

Solution/Drops 0.1%

Click here

Brimonidine tartrate

Ophthalmic

Solution/Drops 0.2%

Click here

Brimonidine tartrate

Ophthalmic

Solution/Drops 0.15%

Click here

Brinzolamide

Ophthalmic

Suspension/Drops 1%

Click here

Doxorubicin HCl

Injectable

Injection, Liposome

Click here

Ethinyl estradiol/levonorgestrel

Oral

Tablet

Click here

Hydrocodone bitartrate/ibuprofen

Oral

Tablet

Click here

Ketoconazole

Topical

Foam, Aerosol 2%

Click here

Memantine HCl

Oral

Tablet

Click here

Memantine HCl

Oral

Capsule, Extended Release

Click here

Methylprednisolone acetate

Injection

Suspension

Click here

Nebivolol HCl

Oral

Tablet

Click here

Nisoldipine

Oral

Tablet, Extended Release

Click here

Phenytoin sodium

Oral

Capsule, Extended Release

Click here

Phenytoin sodium

Oral

Capsule, Extended Release

Click here

Sevelamer carbonate

Oral

Suspension

Click here

Sevelamer HCl

Oral

Tablet

Click here

The draft guidance documents recommend whatin vivoandin vitrostudies 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, FDA now has 1,236 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.

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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 Jan 30]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: USFDA

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