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FDA releases 47 new and revised bioequivalence guidelines for generics Posted 19/02/2016

Generics makers have a whole host of new bioequivalence documents to go through. The US Food and Drug Administration (FDA) announced on 27 January 2016 that it had released 35 new draft guidance documents and 12 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.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 oral contraceptive ethinyl estradiol/norethindrone acetate, antipsychotic Zyprexa (olanzapine), corticosteroid drug prednisone and acid relux treatment Zantac (ranitidine), among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of menopause hot flashes treatment drospirenone/estradiol, attention deficit hyperactivity disorder (ADHD) treatment Estulic/Tenex (guanfacine) and Alzheimer’s/Parkinson’s Disease treatment Exelon (rivastigmine), see Table 2.

Table 1: FDA new draft bioequivalence guidance documents

Active ingredient

Route of administration

Dosage form

Link

Alprostadil

Urethral

Supository

Click here

Atazanavir sulfate/cobicistat

Oral

Tablet

Click here

Beclomethasone dipropionate

Inhalation

Metered aerosol

Click here

Betamethasone dipropionate

Topical

Lotion (augmented)

Click here

Betamethasone valerate

Topical

Lotion

Click here

Betaxolol HCI

Ophthalmic

Suspension/drops

Click here

Ciclesonide

Inhalation

Metered aerosol

Click here

Clobetasol propionate

Topical

Ointment

Click here

Desonide

Topical

Cream

Click here

Desonide

Topical

Lotion

Click here

Diflorasone diacetate (Orange book 075508)

Topical

Cream

Click here

Diflorasone diacetate (Orange book 076263)

Topical

Cream

Click here

Difluprednate

Ophthalmic

Emulsion

Click here

Elvitegravir

Oral

Tablet

Click here

Erythromycin

Oral

Tablet

Click here

Ethinyl estradiol/norethindrone acetate

Oral

Tablet

Click here

Flurandrenolide

Topical

Lotion

Click here

Formoterol fumarate/mometasone furoate

Inhalation

Metered aerosol

Click here

Ingenol mebutate

Topical

Gel (0.05%)

Click here

Ingenol mebutate

Topical

Gel (0.015%)

Click here

Mercaptopurine

Oral

Suspension

Click here

Methylphenidate HCl

Oral

ER Capsule

Click here

Metronidazole

Oral

Capsule

Click here

Mometasone furoate

Topical

Ointment

Click here

Naftifine HCl

Topical

Cream

Click here

Naftifine HCl

Topical

Gel

Click here

Nicotine

Nasal

Metered spray

Click here

Olanzapine pamoate

Intramuscular

ER suspension

Click here

Omega-3 carboxylic acids

Oral

Capsule

Click here

Prednisone

Oral

Tablet

Click here

Ranitidine HCl

Oral

Capsule

Click here

Riociguat

Oral

Tablet

Click here

Spinosad

Topical

Suspension

Click here

Trametinib dimethyl sulfoxide

Oral

Tablet

Click here

Vorapaxar sulfate

Oral

Tablet

Click here

ER: extended release; HCI: hydrochloride.

Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient

Route of administration

Dosage form

Link

Abiraterone acetate

Oral

Tablet

Click here

Amphotericin B

Injection

Liposome

Click here

Ciprofloxacin HCl/hydrocortisone

Otic

Suspension/drops

Click here

Colesevelam HCl

Oral

Powder, suspension

Click here

Drospirenone/estradiol

Oral

Tablet

Click here

Guanfacine HCl

Oral

ER tablet

Click here

Lamotrigine

Oral

ER tablet

Click here

Lidocaine

Topical

Patch

Click here

Lomitapide mesylate

Oral

Capsule

Click here

Methylphenidate HCl

Oral

ER capsule

Click here

Phytonadione

Oral

Tablet

Click here

Rivastigmine Tartrate

Oral

Capsule

Click here

ER: extended release; HCI: hydrochloride.

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, FDA now has 1,397 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 2016 Feb 19]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: USFDA

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