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FDA releases bioequivalence guidance for 26 generics

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On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question.

The draft guidance documents cover generics of Merck’s high cholesterol treatment Lipruzet (atorvastatin, ezetimibe), Pfizer’s cancer drug Inlyta (axitinib), Reckitt Benckiser’s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.

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Source: FDA