We mentioned the delay in publication of OGD statistics a couple of days ago in our post here.  There has also been a delay, caused by the reduction in force at the OGD, of the publication of quarterly product-specific guidance documents (PSGs), but now the wait is over!  According to the FDA announcement here, “[t]oday’s batch of 48 PSGs (34 new and 14 revised) contains:

  • 37 PSGs for products with no approved ANDAs (including 6 complex products)
  • 13 PSGs for complex products (10 new and 3 revised PSGs)
  • PSGs for products used for treatment of postpartum depression, Duchenne muscular dystrophy, and other conditions.
  • Additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs include reference products used for the treatment of conditions such as bronchoconstriction, asthma, chronic obstructive pulmonary disease, allergic reactions, and other conditions.”

In addition, the FDA noted the following “Noteworthy PSGs in Today’s Batch:

  • New PSG for Treatment or Prevention of Bronchoconstriction and to Reduce Risk of Exacerbations in Patients with Asthma Albuterol Sulfate; Budesonide Inhalation Metered Aerosol (Reference Listed Drug (RLD): AIRSUPRA, NDA 214070)
  • New PSG for Maintenance Treatment of Chronic Obstructive Pulmonary Disease Budesonide; Formoterol Fumarate Inhalation Metered Aerosol (RLD: SYMBICORT AEROSPHERE, NDA 216579)
  • New and Revised PSGs for Epinephrine
  • Revised PSG for Temporary Relief of Mild Symptoms of Intermittent Asthma Epinephrine Inhalation Metered Aerosol (RLD: PRIMATENE MIST, NDA 205920)
  • New PSG for Emergency Treatment of Type I Allergic Reactions Epinephrine Nasal Spray (RLD: NEFFY, NDA 214697)
  • New PSG for Hypotension Associated with Septic Shock Epinephrine Intravenous Solution (RLD: ADRENALIN, NDA 215875)
  • New PSGs for new dosage forms approved via Suitability Petitions Carbinoxamine Maleate Oral Disintegrating Tablet (RLD: CLISTIN, NDA 008955) Metformin Hydrochloride Oral Chewable Tablet (RLD: GLUCOPHAGE, NDA 020357)”

Each of the new PSGs identified in the last bullet point above, for recommendations for BE study requirements for new solid oral dosage forms approved through an ANDA suitability petition, have the FDA requesting more data than just a fasting study until a reference standard for the proposed suitability petitioned dosage form change is first approved.  The requirements will revert back to a single fasting study for subsequent ANDAs once the first ANDA is approved for the proposed dosage form.

Always check the new and revised PSGs to ensure that your development program stays on track without unnecessary expense if the FDA’s BE requirements change.