On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question.
The draft guidance documents cover generics of Merck’s high cholesterol treatment Lipruzet (atorvastatin, ezetimibe), Pfizer’s cancer drug Inlyta (axitinib), Reckitt Benckiser’s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 |
|
Atorvastatin, |
Oral |
Tablet |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Axitinib |
Oral |
Tablet |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Brinzolamide |
Ophthalmic |
Suspension/ |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Buprenorphine |
Sublingual |
Film |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Buprenorphine |
Transdermal |
Film, |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Clobazam |
Draft |
Oral |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Desoximetasone |
Topical |
Cream |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Desoximetasone |
Topical |
Ointment |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Diazoxide |
Oral |
Suspension |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Erythromycin |
Oral |
Tablet, |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Estradiol |
Transdermal |
Film, |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Fentanyl Citrate |
Nasal |
Spray, |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Guaifenesin |
Oral |
Tablet, |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Hydrochlorothiazide/ |
Oral |
Tablet, |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Levonorgestrel |
Intrauterine |
Device, |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Levonorgestrel |
Intrauterine |
Device, |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Linagliptin/metformin |
Oral |
Tablet |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Mesalamine |
Oral |
Capsule, |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Perampanel |
Oral |
Tablet |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Pindolol |
Oral |
Tablet |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Prednisolone Acetate |
Ophthalmic |
Suspension/ |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Rabeprazole Sodium |
Oral |
Capsule, |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Teriflunomide |
Oral |
Tablet |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Tranylcypromine |
Oral |
Tablet |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
|
Verteporfin |
Injection, |
Liposome |
http://www.fda.gov/downloads/Drugs/GuidanceCompliance |
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
