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FDA asks for input on product-specific generics guidelines

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In order to further facilitate the availability of generics and to assist the generics industry with identifying the most appropriate methodology for developing drugs, the US Food and Drug Administration (FDA) has released 19 new draft guidance documents and 19 revisions to guidance documents.

The documents, which were released on 1 June 2016, cover the bioequivalence requirements for the development of generics containing 33 different active ingredients.

The new draft bioequivalence guidance documents cover generics of eczema skin treatment Fluonex (fluocinonide), non-steroidal anti-inflammatory drug (NSAID) meloxicam, melanoma treatment Cotellic (cobimetinib), and organ transplant anti-rejection drug Prograf (tacrolimus), among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of asthma treatment Ventolin (albuterol), acid reflux treatment lansoprazole, and Crohn’s disease treatment mesalamine, see Table 2
Table 1: FDA new draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Amcinonide	Topical	Lotion	Click here
Cariprazine HCl	Oral	Capsule	Click here
Cobimetinib fumarate	Oral	Tablet	Click here
Empagliflozin/ metformin HCl	Oral	Tablet	Click here
Erythromycin ethylsuccinate	Oral	Granule	Click here
Everolimus	Oral	Tablet	Click here
Flibanserin	Oral	Tablet	Click here
Fluocinonide	Topical	Gel	Click here
Fluocinonide	Topical	Ointment	Click here
Hydrocortisone	Topical	Solution	Click here
Lesinurad	Oral	Tablet	Click here
Meloxicam	Oral	Capsule	Click here
Methylergonovine maleate	Oral	Tablet	Click here
Ombitasvir/ paritaprevir/ritonavir	Oral	Tablet	Click here
Prednicarbate	Topical	Ointment	Click here
Propofol	Injectable	Injection	Click here
Pseudoephedrine HCl	Oral	ER tablet	Click here
Selexipag	Oral	Tablet	Click here
Tacrolimus	Oral	ER tablet	Click here
ER: extended release; HCl: hydrochloride.

Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Acetaminophen/ hydrocodone bitartrate	Oral	Tablet	Click here
Albuterol sulfate	Oral	Tablet	Click here
Azelastine HCl/ fluticasone propionate	Nasal	Spray	Click here
Benzoyl peroxide/ clindamycin phosphate	Topical	Gel	Click here
Dexamethasone/ tobramycin	Ophthalmic	Ointment	Click here
Dexamethasone (0.05%)/tobramycin (0.3%)	Ophthalmic	Suspension	Click here
Dexamethasone (0.1%)/tobramycin (0.3%)	Ophthalmic	Suspension	Click here
Lansoprazole	Oral	DR tablet	Click here
Loteprednol etabonate/ tobramycin	Ophthalmic	Suspension	Click here
Loteprednol etabonate	Ophthalmic	Suspension/ drops	Click here
Mesalamine	Oral	DR capsule	Click here
Mesalamine	Oral	DR tablet 800 mg	Click here
Mesalamine	Oral	DR tablet 1200 mg	Click here
Methylphenidate HCl	Transdermal	ER film	Click here
Morphine sulfate	Oral	ER capsule	Click here
Paroxetine HCl	Oral	ER tablet	Click here
Pomalidomide	Oral	Capsule	Click here
Prednisolone acetate	Ophthalmic	Suspension/ drops	Click here
Rimexolone	Ophthalmic	Suspension/ drops	Click here
DR: delayed release; ER: extended release; HCl: 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 1,454 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.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 24]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: US FDA