FDA Clears Way for Generics of 26 Popular Drugs

| 03 April 2014 |  By 

The US Food and Drug Administration (FDA) has released 26 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence.


Bioequivalence refers to the "absence of a significant difference" between the bioavailability-specifically the extent and rate of absorption-of two (supposed) pharmaceutical drug equivalents over the course of a period of time, at the same dose and under the same conditions. "The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug," FDA explains on its website.

Drugs that are deemed to be bioequivalent are, for regulatory purposes, essentially the same.

But in practical terms, generic drug companies are often most concerned with two things:

  • How to prove that two drugs are bioequivalent
  • How to show bioequivalency in a way that will be acceptable to FDA

In order to facilitate that process, FDA regularly publishes what it calls "bioequivalence recommendations for specific products," which as of April 2014 contains more than 1,150 recommendations.

These recommendations most often contain the recommended number of bioequivalence studies that must be conducted in order to obtain approval, as well as the general designs of the study, acceptable parameters of bioequivalency, and any other considerations sponsors must keep in mind.

New Standards

On 2 April 2014, FDA released 26 new BE standards, including ones for generic versions of Merck's Lipruzet (atorvastatin, ezetimibe), Pfizer's Inlyta (axitinib), Reckitt Benckiser's Suboxone (buprenorphine HCl; naloxone HCl), Purdue's Butrans (Buprenorphine), Lundbeck's Onfi (Clobazam), transdermal estradiol, and intrauterine levonorgestrel.

Those guidances are still in draft form. FDA also said it had finalized 16 other BE guidances.

New Draft Product-Specific BE Recommendations for Drug Products
Active IngredientRoute of AdministrationDosage FormRLD#
Amphotericin BInjectionLiposome50740
Atorvastatin, EzetimibeOralTablet200153
Buprenorphine HCl; Naloxone HClSublingualFilm022410
BuprenorphineTransdermalFilm, Extended Release21306




ErythromycinOralTablet, Delayed Release62298
EstradiolTransdermalFilm, Extended Release203752
Fentanyl CitrateNasalSpray, Metered22569
GuaifenesinOralTablet, Extended Release21282
Hydrochlorothiazide/Metoprolol SuccinateOralTablet, Extended Release21956
LevonorgestrelIntrauterineDevice, Intrauterine 13.5 mg.203159
LevonorgestrelIntrauterineDevice, Intrauterine 52 mg.21225
Linagliptin/Metformin HClOralTablet201281
MesalamineOralCapsule, Delayed Release204412
Prednisolone AcetateOphthalmicSuspension/Drops17011
Rabeprazole SodiumOralCapsule, Delayed Release204736
Tranylcypromine SulfateOralTablet12342
VerteporfinInjection, IntravenousLiposome21119

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