FDA releases 67 new and revised bioequivalence guidelines for generics

INICIO/Directrices | Posted 18/11/2016 post-comment0 Post your comment

As part of its ongoing efforts to provide product specific guidance for generics makers the US Food and Drug Administration (FDA) has again released a whole host of new bioequivalence documents. The agency announced on 1 October 2016 that it had released 34 new draft guidance documents and 33 revisions to guidance documents on bioequivalence requirements for the development of generics containing 59 different active ingredients.

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The new draft bioequivalence guidance documents cover generics of non-steroidal anti-inflammatory drug (NSAID) painkiller ibuprofen, HIV treatment Viread (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), acid reflux treatment Nexium (esomeprazole) and oral corticosteroid triamcinolone, among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of NSAID arthritis treatment diclofenac, menopause hot flashes treatment estradiol, oral contraceptive ethinyl estradiol/norethindrone acetate and Alzheimer’s/Parkinson’s disease treatment Exelon (rivastigmine), among others, see Table 2.

This is the third time FDA has released new and revised bioequivalence guidance for generics in 2016. The agency also released 31 new draft guidance documents and 11 revisions in January 2016. This was followed by 19 new draft guidance documents and 19 revisions in June 2016

Table 1: FDA new draft bioequivalence guidance documents

Active ingredient Route of administration Dosage form Link
Acetaminophen/ oxycodone hydrochloride Oral Tablet ER Click here
Alectinib hydrochloride Oral Capsule Click here
Betamethasone dipropionate Topical Cream Click here
Betamethasone valerate Topical Ointment Click here
Captopril Oral Tablet Click here
Carbidopa/levodopa Oral Tablet Click here
Cholic acid Oral Capsule Click here
Clobetasol propionate Topical Cream (emollient) Click here
Clobetasol propionate Topical Gel Click here
Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide fumarate Oral Tablet Click here
Crotamiton Topical Cream Click here
Crotamiton Topical Lotion Click here
Desonide Topical Ointment Click here
Dexlansoprazole Oral Tablet DR/OR  Click here
Elbasvir/grazoprevir Oral Tablet Click here
Eltrombopag olamine Oral Suspension Click here
Esomeprazole magnesium Oral Tablet DR Click here
Fluticasone propionate Topical Ointment Click here
Halobetasol propionate Topical Lotion Click here
Hydrocodone bitartrate Oral Capsule ER Click here
Hydrocodone bitartrate Oral Tablet ER Click here
Hydrocortisone valerate Topical Ointment Click here
Ibuprofen Oral Suspension Click here
Iron dextran Injectable Injection Click here
Methylphenidate HCl Oral Tablet, chewable Click here
Morphine sulfate Oral Solution Click here
Olopatadine HCI Nasal Spray, metered Click here
Oxymorphone HCl Oral Tablet ER Click here
Prochlorperazine Rectal Suppository Click here
Pyrazinamide Oral Tablet Click here
Rolapitant Oral Tablet Click here
Triamcinolone acetonide Nasal Spray, metered Click here
Triamcinolone acetonide Topical Ointment Click here
Umeclidinium bromide Inhalation Powder Click here
ER: extended release; DR: delayed release; OD: orally disintegrating.

Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient Route of administration Dosage form Link
Bacitracin Ophthalmic Ointment Click here
Buprenorphine Transdermal Film ER Click here
Cyclosporine Ophthalmic Emulsion Click here
Dexlansoprazole Oral Capsule DR Click here
Diclofenac epolamine Topical Patch Click here
Erythromycin Ophthalmic Ointment Click here
Estradiol (Orange book 203752) Transdermal Film ER Click here
Estradiol (Orange book 19081) Transdermal Film ER Click here
Estradiol (Orange book 20375/21674) Transdermal Film ER Click here
Estradiol (Orange book 20538) Transdermal Film ER Click here
Ethinyl estradiol/norelgestromin Transdermal Film ER Click here
Fentanyl Transdermal Film ER Click here
Granisetron Transdermal Film ER Click here
Icosapent ethyl Oral Capsule Click here
Lansoprazole Oral Tablet DR/OD Click here
Lidocaine Topical Patch Click here
Menthol/methyl salicylate Topical Patch Click here
Mesalamine Oral Tablet DR Click here
Methylphenidate Transdermal Film ER Click here
Morphine sulfate Oral Capsule ER Click here
Nicotine Transdermal Film ER Click here
Nitroglycerin (Orange book 20145) Transdermal Film ER Click here
Nitroglycerin (Orange book 20145) Transdermal Film ER Click here
Omega-3-acid ethyl esters Oral Capsule Click here
Oxycodone HCl Oral Tablet ER Click here
Oxybutynin Transdermal Film ER Click here
Pantoprazole sodium Oral Granules DR suspension Click here
Rivastigmine Transdermal Film ER Click here
Rotigotine Transdermal Film ER Click here
Scopolamine Transdermal Film ER Click here
Selegiline Transdermal Film ER Click here
Testosterone Transdermal Film ER Click here
ER: extended release; DR: delayed release; OD: orally disintegrating.

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 timepoints and analytes to be measured in blood samples are also detailed in the draft guidance documents.

In total, FDA now has 1,523 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.

Related article
Doctors in the US should remember to prescribe generics

Reference
1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: FDA

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