Today, the FDA issued 44 new and 37 revised draft product specific guidances (PSGs) outlining FDA’s current thinking on the requirements for establishing bioequivalence to reference listed drugs or reference standards.  None of the guidance documents were finalized in the current listings.

According to the FDA Email, the 81 guidance documents included (and yes, I know the numbers in the first two bullets don’t add up that is because some of the PSGs fall into two categories).

  • 54 PSGs for products with no approved ANDAs (including 19 complex products)
  • 28 PSGs for complex products (7 new and 21 revised PSGs)
  • PSGs for products used for treatment of resistant bacterial infections, cystic fibrosis, lung and thyroid cancers, seizures associated with Dravet syndrome, and other conditions
  • Some additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs reference products were used for first-in-class topical therapy for psoriasis patients and treatment of seborrheic dermatitis, wounds associated with dystrophic and junctional epidermolysis bullosa, and other conditions.

The FDA identified the following noteworthy guidances issued today as:

  • New PSG for treatment of seborrheic dermatitis; roflumilast topical foam (RLD: ZORYVE, NDA 217242)
  • New PSG for treatment of rare skin conditions, dystrophic epidermolysis bullosa and junctional epidermolysis bullosa; birch triterpenes topical gel (RLD: FILSUVEZ, NDA 215064)
  • Revised PSG to include a characterization-based BE approach for non-steroidal adjunct therapy for psoriasis; tapinarof topical cream (RLD: VTAMA, NDA 217806)
  • Revised PSGs for multiple modified-release drug products to remove in vitro alcohol dose dumping studies due to new GDUFA-funded research that suggests such studies are not needed: carbinoxamine maleate oral extended release suspension; (RLD: KARBINAL ER NDA 022556); carvedilol phosphate oral extended release capsule (RLD: COREG CR, NDA 022012); diltiazem hydrochloride oral extended release capsule (RLD: CARDIZEM CD, NDA 020062); posaconazole oral delayed release for suspension (RLD: NOXAFIL POWDERMIX KIT, NDA 214770); trospium chloride oral extended release capsule (RLD: SANCTURA XR, NDA 022103)
  • Revised PSGs for complex peptides to clarify recommendations on the conduct of in vitro innate immune response assays, and when recombinant generic peptides can be submitted through the generic pathway. These include calcitonin (RLD: CALCIMAR, NDA 017769); glucagon (RLD: BAQSIMI, GVOKE, NDA 210134, 212097); dasiglucagon (RLD: ZEGALOGUE, NDA 214231); pegcetacoplan (RLD: EMPAVELI, SYFOVRE, NDA 215014, 217171); tirzepatide (RLD: MOUNJARO, NDA 215866); teriparatide (RLD: FORTEO, NDA 021318); liraglutide (RLD: VICTOZA, SAXENDA, NDA 022341, 206321); semaglutide (RLD: WEGOVY, NDA 215256); vosoritide (RLD: VOXZOGO, NDA 214938).

The FDA has been very busy at the end of the year providing industry with a lot of forward-looking advice as well as clarifying, revising or refining older PSG guidances based on industry comments or internal FDA reevaluation.