Regulatory Focus™ > News Articles > FDA Releases Dozens of New, Revised Bioequivalence Draft Guidance Documents

FDA Releases Dozens of New, Revised Bioequivalence Draft Guidance Documents

Posted 13 September 2012 | By Alexander Gaffney, RAC 

US regulators will be making available dozens of new and revised product-specific bioequivalence draft guidance documents, the US Food and Drug Administration (FDA) announced on 12 September.

In a Federal Register notice, FDA said the new and revised draft guidance documents are intended for sponsors of abbreviated new drug applications (ANDAs), which are used obtain FDA approval for generic drugs under the Drug Price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 Though not published individually in the federal register, the draft guidance documents will be made available on FDA's website and will be made available for comment through 13 November 2012.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:

  1. Amoxicillin
  2. Amoxicillin; clavulanate potassium
  3. Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
  4. Budesonide
  5. Bupropion hydrochloride (multiple reference listed drugs (RLDs)) 
  6. Calcitonin salmon
  7. Carbidopa; levodopa
  8. Carglumic acid
  9. Ciclesonide
  10. Ciprofloxacin; dexamethasone 
  11. Cyclophosphamide
  12. Dalteparin sodium
  13. Estramustine phosphate sodium 
  14. Fentanyl citrate
  15. Ketoconazole
  16. Linagliptin
  17. Mesalamine (multiple RLDs and dosage forms)
  18. Methylphenidate hydrochloride (multiple RLDs)
  19. Nifedipine
  20. Omega-3-acid ethyl esters
  21. Omeprazole
  22. Paclitaxel
  23. Pazopanib hydrochloride
  24. Progesterone
  25. Rilpivirine hydrochloride
  26. Roflumilast
  27. Saxagliptin hydrochloride
  28. Telaprevir
  29. Tenofovir disoproxil fumarate
  30. Thioguanine
  31. Thalidomide
  32. Tretinoin (multiple RLDs and dosage forms)

Revised Draft Guidances:

  1. Azacitidine
  2. Azelaic acid
  3. Capecitabine
  4. Estrogen, esterified
  5. Etravirine
  6. Hydrochlorothiazide; losartan potassium
  7. Lopinavir; ritonavir
  8. Phytonadione (multiple RLDs and dosage forms)
  9. Propranolol hydrochloride
  10. Sapropterin dihydrochloride
  11. Sumatriptan
  12. Tadalafil
  13. Theophylline (multiple RLDs)
  14. Tolterodine tartrate
  15. Topiramate
  16. Trazodone hydrochloride

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