It is no small task to get a guidance document issued by the FDA in normal operating times but in the face of the longest government shutdown in history, the issuance of 76 PSGs (32 new and 44 revised) is nothing short of amazing.

Yesterday, the FDA announced the new and revised guidance documents’ availability on its website (here).  In an announcement (here), the Agency described the guidances as follows:

  • 64 PSGs for products with no approved ANDAs (including 27 for complex products)
  • 29 PSGs for complex products (7 new and 22 revised PSGs)
  • PSGs for products used for treatment of non-small-cell lung cancer, Parkinson’s disease, chronic myeloid leukemia, brain cancer, and other conditions

The notice summarizes noteworthy PSGs in today’s batch of PSGs as:

  • New PSG for adjunct therapy for chronic weight management in adults; tirzepatide subcutaneous solution (reference listed drug (RLD): ZEPBOUND, NDA 217806)
  • New PSG for treatment of macular edema; dexamethasone intravitreal implant (RLD: OZURDEX, NDA 022315)
  • New PSG for asthma; flunisolide inhalation aerosol (RLD: AEROSPAN HFA, NDA 021247)
  • Multiple revised PSGs for treatment of chronic obstructive pulmonary disease (COPD); aclidinium bromide inhalation metered powder (RLD: TUDORZA PRESSAIR, NDA 202450), aclidinium bromide; formoterol fumarate inhalation metered powder (RLD: DUAKLIR PRESSAIR, NDA 210595), budesonide inhalation metered powder (RLD: PULMICORT FLEXHALER, NDA 021949), glycopyrrolate inhalation powder (RLD: SEEBRI, NDA 207923), glycopyrrolate; indacaterol maleate inhalation metered powder (RLD: UTIBRON, NDA 207930), indacaterol maleate inhalation metered powder (RLD: ARCAPTA NEOHALER, NDA 022383), and ipratropium bromide (RLD: ATROVENT HFA, NDA 021527)

The AAM GRx+Biosims meeting last week included a session on the development and issuance of PSGs, and this batch is an early, unexpected pot of gold for prospective ANDA applicants for generic versions of these products, especially since previous additions to the PSGs have been delayed since the beginning of the year when the turmoil began at the FDA.  Many of the drugs identified in this recent listing are complex products that required considerable research and collaboration among various Agency components to provide the industry with the FDA’s current thinking on methods for establishing bioequivalence between the generic and its brand-name counterpart.  The FDA also noted that “eligible applicants may request a PSG teleconference to obtain FDA’s feedback on the potential impact of a new or revised PSG on its development program and a subsequent PSG meeting following feedback received at the PSG teleconference.”  The Guidance for Industry titled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA can be found here.