FDA Revises Draft Guidance with Product-Specific Bioequivalence Recommendations

September 23, 2015

On June 11, 2010, FDA announced the availability of a guidance entitled “Bioequivalence Recommendations for Specific Products.” This document “explained the process that would be used to make product-specific bioequivalence (BE) recommendations available to the public on FDA’s Web site.” The process, defined in the original guidance, was adopted by FDA in an attempt to disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations.

FDA collects draft recommendations, which are posted on its website and announced in the Federal Register from time to time, and asks the public to submit comments within 60 days of the announcement. After the comment period is closed, “FDA considers any comments received and either publishes final recommendations or publishes draft recommendations,” which are then available for comment.

On June 30, 2015, FDA announced the most recent recommendations in the Federal Register. Both new and revised draft guidances with product-specific recommendations were available from the Agency earlier this week. These “recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs),” and include:

  1. New draft product-specific BE recommendations are available for drug products containing the following active ingredients:
  • Aclidinium bromide
  • Acyclovir
  • Aminocaproic acid
  • Apremilast
  • Benazepril hydrochloride; Hydrochlorothiazide
  • Brimonidine tartrate
  • Carbidopa; Levodopa
  • Ceritinib
  • Clobetasol propionate
  • Clomipramine hydrochloride
  • Clonidine hydrochloride
  • Cobicistat
  • Cysteamine bitartrate
  • Dapagliflozin propanediol; Metformin hydrochloride
  • Dasabuvir sodium; Ombitasvir; Paritaprevir; Ritonavir
  • Desvenlafaxine fumarate
  • Eslicarbazepine acetate
  • Ferric citrate
  • Fluticasone propionate (multiple reference listed drugs)
  • Formoterol fumarate
  • Idelalisib
  • Ledipasvir; Sofosbuvir
  • Levocarnitine
  • Loperamide hydrochloride; Simethicone
  • Mometasone furoate monohydrate
  • Naltrexone HCL; Bupropion HCL
  • Netupitant; Palonosetron hydrochloride
  • Nintedanib esylate
  • Nortriptyline hydrochloride
  • Pirfenidone
  • Pomalidomide
  • Ponatinib hydrochloride
  • Rivaroxaban
  • Ruxolitinib phosphate
  • Suvorexant
  • Tasimelteon
  • Tedizolid phosphate
  • Tramadol hydrochloride
  • Trimipramine maleate


  1. Revised draft product-specific BE recommendations are available for drug products containing the following active ingredients:
  • Acitretin
  • Amantadine hydrochloride
  • Benzonatate
  • Carbamazepine
  • Colesevelam hydrochloride
  • Cyclophosphamide
  • Dabigatran etexilate mesylate
  • Dasatinib
  • Desvenlafaxine succinate
  • Esomeprazole magnesium
  • Estradiol
  • Ethinyl estradiol; Norethindrone
  • Gabapentin
  • Isotretinoin
  • Minocycline hydrochloride
  • Naltrexone
  • Sevelamer carbonate
  • Sirolimus

Do these recommendations apply to your drug? We know following the rules and regulations as they change can be difficult, and that is why we are here to help. We can work with you to ensure your product(s) are compliant and you are up to date with all FDA regulations. For more information about our services and how we can help you, please contact us.

Quality & Compliance GMP

September 23, 2015

FDA’s CBER Announces Invitation to Participate in the Regulatory Site Visit Training Program

On February 2, 2016, the FDA’s Center for Biologics Evaluation and Research (CBER) published its annual invitation for biologics facilities to participate in the Regulatory Site Visit Training...

Read More
Agency Alerts General Regulatory

September 23, 2015

FDA Extends Comment Period For Its “Request for Quality Metrics” Draft Guidance

Last month, FDA published a draft guidance titled “Request for Quality Metrics,” which outlined the ways in which it intends to collect and use quality metrics. The guidance states that the data will...

Read More
Agency Alerts General Regulatory

September 23, 2015

Endo Pharmaceuticals Recalls Self-Injected Erectile Dysfunction Drug Due to Concerns Over Sterility

On Friday, February 24th, FDA issued a press release stating that Endo Pharmaceuticals Inc. is recalling one lot of Edex® (alprostadil for injection) 10 mcg. What is Edex? Edex is a prescription only...

Read More