Today, the FDA issued a total of thirty Product Specific Guidances (PSGs) – twenty‑one new and nine revised (here).  The FDA notes that all twenty‑one newly issued PSGs are for drug products for which there are no approved ANDAs.

In addition, of the thirty guidances issued, nineteen are for complex products (fourteen new and five revised).  The Agency called out four noteworthy new PSGs:

  • Dihydroergotamine mesylate nasal spray (RLD: Trudhesa) for treatment of migraine and notes that even though it is a nasal spray product because it has a propellant associated with the drug- device combination, the FDA is recommending an in vivo component along with in vitro testing to support a bioequivalence (BE) determination even if the products are Q1 and Q2 the same.
  • Glucogon nasal powder (RLD: Baqsim) for treatment of severe hypoglycemia in diabetic patients. This is the first peptide-based active ingredient using a powder formulation. Both in vivo and in vitro tests are recommended to establish BE.  In addition the FDA is providing recommendations for establishing immunogenicity risks.
  • Afamelanotide Sub-Q implant (RLD: Scenesse) which is a treatment for prevention of phototoxicity in adult patients with erythropoietic protoporphyria where the FDA is recommending a fourteen‑day PK BE study with patrial AUC and Cmax being the primary parameters for establishing BE.
  • Traimcinolone acetonide injectable suspension (RLD: Xipere) used for the treatment of macular edema associated with uvetis for suprachoroidal injection which represents a new route of administration for an ophthalmic product. This guidance was based on a “totality of evidence” approach developed through GDUFA supported research.

The FDA also notes that, for revised guidances, sponsors should evaluate whether the revisions may impact their product development scheme and they are welcomed to request a PSG teleconference and/or subsequent PSG meetings as outlined in the GDUFA III commitment letter.