Regulatory Focus™ > News Articles > FDA Releases Additional Draft Guidance on Product-Specific Bioequivalence Recommendations

FDA Releases Additional Draft Guidance on Product-Specific Bioequivalence Recommendations

Posted 21 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released additional draft guidance for industry on 21 March entitled Product-specific Bioequivalence Recommendations. The guidance covers 31 new drugs and revises previous guidance for nine existing drugs.

Bioequivalence recommendations are put out by FDA to expedite the development of abbreviated new drug applications (ANDAs), which are used to approve generic drug products. The guidance provides product-specific guidance on the design of bioequivalence studies to support the ANDAs.

The list of new drugs includes:

  • acyclovir (multiple reference listed drugs (RLDs))
  • amiloride
  • butenafine HCl (multiple RLDs),Chlorpromazine HCl
  • clindamycin Phosphate (multiple RLDs)
  • dalfampridine
  • dexmethylphenidate HCl
  • dextromethorphan HBr; Quinidine Sulfate
  • diclofenac Epolamine
  • drospirenone Ethinyl Estradiol; Levomefolate
  • ethinyl Estradiol; Norethindrone
  • fenofibrate
  • fludarabine
  • fulvestrant
  • glyburide (multiple RLDs)
  • granisetron
  • ivermectin
  • ketoconazole (multiple RLDs)
  • memantine HCl
  • metformin Hydrochloride; Saxagliptin
  • naftifine HCl (multiple RLDs)
  • nitrofurantoin; Nitrofurantoin Macrocrystalline
  • ondansetron
  • oxiconazole Nitrate (multiple RLDs)
  • pimecrolimus
  • procarbazine
  • propylthiouracil
  • sumatriptan
  • tacrolimus (multiple strengths)
  • tolvaptan
  • tretinoin (multiple RLDs)
  • vardenafil HCl


Existing drugs with revised bioequivalence guidance include:

  • benzoyl Peroxide; Clindamycin Phosphate (multiple RLDs)
  • bosentan
  • cholestyramine
  • colesevelam
  • dexamethasone; Tobramycin (multiple RLDs)
  • hydrochlorothiazide; Irbesartan
  • loteprednol
  • loteprednol; Tobramycin
  • paliperidone


Read more:

Bioequivalence Recommendations for Specific Products

Federal Register - Draft Guidance for Industry; Availability: Product-Specific Bioequivalence Recommendations


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