FDA Revises Draft Guidance with Product-Specific Bioequivalence Recommendations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.




Agency Alerts General Regulatory

August 28, 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 the Full Article
Agency Alerts General Regulatory

September 17, 2015

FDA To Increase Tropical Disease Priority Review User Fee Rate In 2016

Starting October 1, 2015, the FDA tropical disease priority review user fee rate is set to increase to $2,727,000, up nearly $200,000 from 2015’s rate of $2,562,000. Under the Prescription Drug User...

Read the Full Article
Agency Alerts

May 26, 2016

FDA to Review Second Remicade Biosimilar Product

Earlier this week Samsung Bioepis announced that FDA has accepted for review its BLA for SB2, a biosimilar version of Remicade (infliximab).  SB2 is indicated for the treatment of rheumatoid...

Read the Full Article