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On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question.

Guidance V13F21

The draft guidance documents cover generics of Merck’s high cholesterol treatment Lipruzet (atorvastatin, ezetimibe), Pfizer’s cancer drug Inlyta (axitinib), Reckitt Benckiser’s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

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