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:
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
