FDA Publishes Guidance for Generic Drug Development


FDA provides manufacturers with product-specific guidances for creating equivalent generic drugs.

Yesterday, the FDA released a list of 48 product-specific guidances to increase the development of generic drugs. The finalized guidances indicate the agency’s expectations on how to develop generics that are therapeutically equivalent to certain branded drugs, according to a press release.

To successfully create generics, manufacturers should understand that the drug must be pharmaceutically equivalent to its reference listed drug (RLD), according to the FDA. They wrote that generics must have the same active ingredients, dosage form, strength, and route of administration.

Generic drugs also must be bioequivalent to the RLD, meaning that there are no significant differences in the rate and extent of absorption of the drug. Additionally, generics must be therapeutically equivalent to the RLD, the FDA noted.

According to 21 CFR 320.24, different evidence can be used to determine bioequivalence for generics, including in vivo, in vitro, or both types of studies. The FDA requires that the drugs are tested using the most accurate, sensitive, and reproducible methods.

To further increase generic drug production, the FDA created several new product-specific guidances. Since July 1, 2017, the FDA has added 21 new drugs and made 13 revisions. In total, there are now 48 product-specific guidances aimed to increasing the production of generics, according to the FDA.

New Guidances:

  • Aspirin; Omeprazole
  • Aspirin
  • Brexpiprazole
  • Brivaracetam
  • Cefdinir
  • Clocortolone pivalate
  • Cyanocobalamin
  • Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir
  • Dextroamphetamine sulfate
  • Diclofenac sodium
  • Fluphenazine HCl
  • Gentamicin sulfate
  • Glycopyrrolate
  • Obeticholic Acid
  • Silver sulfadiazine
  • Tenofovir alafenamide fumarate
  • Tiopronin
  • Trifluridine; Tipiracil
  • Triamcinolone acetonide
  • Triamcinolone acetonide
  • Uridine triacetate

New Revisions:

  • Brimonidine Tartrate
  • Dabigatran Etexilate Mesylate
  • Dorzolamide HCl
  • Gefitinib
  • Latanoprost
  • Methoxsalen
  • Metoprolol tartrate
  • Minocycline HCl (Capsule)
  • Minocycline HCl (Tablet)
  • Minoxidil
  • Pimozide
  • Propafenone HCl
  • Tetrabenazine

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