FDA issues additional product-specific guidances for OINDPs

The FDA has issued new and revised product-specific guidances (PSGs) for a number of OINDPs as of June 3, 2020. The agency also updated its list of planned PSGs for complex generics, adding a number of PSGs for OINDPs to that list.

New PSGs issued on June 3 include:

• Glycopyrrolate/indacaterol maleate inhalation powder
• Revefenacin inhalation solution

Revised PSGs issued on June 3 include:

• Azelastine hydrochloride/fluticasone propionate nasal spray
• Dihydroergotamine mesylate nasal spray
• Fluticasone furoate nasal spray
• Fluticasone propionate nasal spray
• Fluticasone propionate/salmeterol xinafoate inhalation aerosol
• Mometasone furoate nasal spray
• Triamcinolone Acetonide nasal spray

Planned new PSGs as of June 3 include:

• Desmopressin acetate nasal spray
• Epinephrine inhalation aerosol
• Esketamine hydrochloride nasal spray
• Fluticasone propionate nasal spray
• Levodopa inhalation powder
• Midazolam nasal spray
• Olodaterol HCL/tiotropium bromide inhalation spray
• Sumatriptan nasal spray
• Tiotropium bromide inhalation spray
• Tobramycin inhalation powder

Planned revised PSGs as of June 3 include:

• Budesonide nasal spray
• Ketorolac tromethamine nasal spray