FDA Issues 67 New & Revised Bioequivalence Study Recommendations for Generic Drug Makers

October 6, 2016

In order for a generic drug to be approved by the FDA, the drug maker must prove that the product is pharmaceutically equivalent to its reference listed drug (RLD).  There are many different types of evidence that can be used to demonstrate bioequivalence, including in vivo testing, in vitro testing, or a combination of both.

To assist with the development and availability of generic drug products, FDA publishes product-specific recommendations, which describe “the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.”  These recommendations are published incrementally and are revised and updated on a regular basis.

On Tuesday, October 4th, the FDA issued 67 product-specific bioequivalence recommendations, of which 34 were new and 33 were revised.

According to an article from RAPS, the Agency “is seeking feedback before finalizing the draft bioequivalence (BE) guidance and the 33 revisions, is focusing on the following new products:

  • Acetaminophen; Oxycodone hydrochloride, which is a pain reliever also known as Percocet
  • Alectinib hydrochloride, which is currently a lung cancer treatment made by Genentech
  • Betamethasone dipropionate, which can be used as a skin ointment
  • Betamethasone valerate, which is also a topical skin treatment
  • Captopril Carbidopa; levodo pa, which is used as a Parkinson’s disease treatment
  • Cholic acid, which is approved to treat bile acid synthesis disorders
  • Clobetasol propionate (multiple reference listed drugs), which is a psoriasis medication
  • Cobicistat; Elvitegravir; Emtricitabine; Tenofovir alafenamide fumarate, which is Gilead’s HIV treatment approved by FDA in November 2015
  • Crotamiton (multiple reference listed drugs), which can treat scabies or severe itching
  • Desonide, which can treat dermatitis and other skin problems
  • Dexlansoprazole, which treats heartburn
  • Elbasvir; grazoprevir, which is better known as Merck’s hepatitis C treatment Zepatier and first approved in January 2016
  • Eltrombopag Olamine, which is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
  • Esomeprazole magnesium, which is AstraZeneca’s Nexium and used to treat acid reflux
  • Fluticasone propionate, which is used to help allergies
  • Halobetasol propionate, which is a skin ointment
  • Hydrocodone bitartrate (multiple reference listed drugs), which is used as a pain treatment
  • Hydrocortisone valerate, which is a cream to treat inflammation
  • Ibuprofen
  • Iron dextran to treat iron deficiency anemia
  • Methylphenidate hydrochloride, which can treat ADHD
  • Morphine sulfate, which is a pain treatment
  • Olopatadine hydrochloride, which can treat eye itching
  • Oxymorphone hydrochloride, which is a pain treatment
  • Prochlorperazine to treat nausea or vomiting and anxiety or schizophrenia
  • Pyrazinamide, which is a tuberculosis treatment
  • Rolapitant hydrochloride, which treats nausea or vomiting associated with chemotherapy
  • Triamcinolone acetonide (multiple reference listed drugs), which is a topical corticosteroid
  • Umeclidinium bromide, which is for patients with chronic obstructive pulmonary disease”

For a full list of the Agency’s product-specific recommendations for generic drug development, visit FDA’s website.

Do any of these recommendations apply to your drug? Have a product that you think is a candidate for an ANDA submission? As the rules and regulations are constantly changing and evolving, we know it can be difficult to stay on top of everything.  That is why we are here to help.  We can work with you to ensure your product(s) are compliant and that you are up to date with all FDA regulations.  To learn more about our services and how we can help you, contact us today.


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