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the most appropriate methodology for developing drugs, the US Food and Drug Administration (FDA) has released 19 new draft guidance documents and 19 revisions to guidance documents.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
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The draft guidance documents recommend what in vivo and in vitro studies generics companies should carry out in order to demonstrate bioequivalence.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.
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 Jun 24]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment