FDA Releases Dozens of New, Revised Bioequivalence Draft Guidance Documents
US regulators will be making available dozens of new and revised product-specific bioequivalence draft guidance documents, the US Food and Drug Administration (FDA) announced on 12 September.
In a Federal Register notice, FDA said the new and revised draft guidance documents are intended for sponsors of abbreviated new drug applications (ANDAs), which are used obtain FDA approval for generic drugs under the Drug Price Competition and Patent Term Restoration Act of 1984. Under the act, companies must show their products are, within certain parameters, bioequivalent to a reference-listed drug.
FDA's draft guidances establish or update its recommendations for companies looking to establish bioequivalence procedures for dozens of drug products. Though not published individually in the federal register, the draft guidance documents will be made available on FDA's website and will be made available for comment through 13 November 2012.
An average bioequivalence guidance contains the recommended number of studies to conduct to show bioequivalence, the general design of the study, the parameters to show bioequivalence, additional testing required in addition to any clinical testing and additional comments regarding clinical endpoints or other considerations sponsors must keep in mind.
New Draft Guidances:
- Amoxicillin
- Amoxicillin; clavulanate potassium
- Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
- Budesonide
- Bupropion hydrochloride (multiple reference listed drugs (RLDs))
- Calcitonin salmon
- Carbidopa; levodopa
- Carglumic acid
- Ciclesonide
- Ciprofloxacin; dexamethasone
- Cyclophosphamide
- Dalteparin sodium
- Estramustine phosphate sodium
- Fentanyl citrate
- Ketoconazole
- Linagliptin
- Mesalamine (multiple RLDs and dosage forms)
- Methylphenidate hydrochloride (multiple RLDs)
- Nifedipine
- Omega-3-acid ethyl esters
- Omeprazole
- Paclitaxel
- Pazopanib hydrochloride
- Progesterone
- Rilpivirine hydrochloride
- Roflumilast
- Saxagliptin hydrochloride
- Telaprevir
- Tenofovir disoproxil fumarate
- Thioguanine
- Thalidomide
- Tretinoin (multiple RLDs and dosage forms)
Revised Draft Guidances:
- Azacitidine
- Azelaic acid
- Capecitabine
- Estrogen, esterified
- Etravirine
- Hydrochlorothiazide; losartan potassium
- Lopinavir; ritonavir
- Phytonadione (multiple RLDs and dosage forms)
- Propranolol hydrochloride
- Sapropterin dihydrochloride
- Sumatriptan
- Tadalafil
- Theophylline (multiple RLDs)
- Tolterodine tartrate
- Topiramate
- Trazodone hydrochloride