FDA releases bioequivalence guidance for 26 generics

On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question.

The draft guidance documents cover generics of Merck’s high cholesterol treatment Lipruzet (atorvastatin, ezetimibe), Pfizer’s cancer drug Inlyta (axitinib), Reckitt Benckiser’s opiod addiction treatment Suboxone (buprenorphine, naloxone), Purdue’s painkiller Butrans (buprenorphine), Lundbeck’s epilepsy treatment Onfi (clobazam) and Bayer’s intrauterine contraceptive Mirena (levonorgestrel), to name just a few, see Table 1.

Active ingredient

Route of administration

Dosage form

Link

Amphotericin B

Injection

Liposome

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384094.pdf

Atorvastatin,
Ezetimibe

Oral

Tablet

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384096.pdf

Axitinib

Oral

Tablet

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384098.pdf

Brinzolamide

Ophthalmic

Suspension/
drops

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384099.pdf

Buprenorphine
Hydrochloride,
Naloxone
Hydrochloride

Sublingual

Film

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384101.pdf

Buprenorphine

Transdermal

Film,
extended
release

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384107.pdf

Clobazam

Draft

Oral

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384108.pdf

Desoximetasone

Topical

Cream

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384110.pdf

Desoximetasone

Topical

Ointment

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384111.pdf

Diazoxide

Oral

Suspension

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384113.pdf

Erythromycin

Oral

Tablet,
delayed
release

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384115.pdf

Estradiol

Transdermal

Film,
extended
release

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384116.pdf

Fentanyl Citrate

Nasal

Spray,
metered

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384118.pdf

Guaifenesin

Oral

Tablet,
extended
release

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384136.pdf

Hydrochlorothiazide/
Metoprolol Succinate

Oral

Tablet,
extended
release

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384139.pdf

Levonorgestrel

Intrauterine

Device,
intrauterine 13.5 mg

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384142.pdf

Levonorgestrel

Intrauterine

Device,
intrauterine
52 mg

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384144.pdf

Linagliptin/metformin

Oral

Tablet

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384147.pdf

Mesalamine

Oral

Capsule,
delayed
release

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384149.pdf

Perampanel

Oral

Tablet

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384154.pdf

Pindolol

Oral

Tablet

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384156.pdf

Prednisolone Acetate

Ophthalmic

Suspension/
drops

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384160.pdf

Rabeprazole Sodium

Oral

Capsule,
delayed
release

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384162.pdf

Teriflunomide

Oral

Tablet

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384164.pdf

Tranylcypromine
Sulfate

Oral

Tablet

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384169.pdf

Verteporfin

Injection,
intravenous

Liposome

http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM384173.pdf

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.

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 http://www.regulations.gov or written comments can be mailed to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Source: www.gabionline.net

Source URL: https://gabi-journal.net/news/fda-releases-bioequivalence-guidance-for-26-generics


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