Table 1.
FDA non-binding product-specific draft guidelines for topical generic semisolid drug products that contain in vitro option for establishing bioequivalence [13].
| Drug | Semisolid Dosage Form | Qualitative and Quantitative Sameness Evaluation | Physicochemical Characterization | In Vitro Release Testing | In Vitro Skin Permeation Testing | Additional In Vivo Study | Year |
|---|---|---|---|---|---|---|---|
| Acyclovir | Ointment | + | + | + | 2019 | ||
| Acyclovir | Cream | + | + | + | + | 2016 | |
| Bexarotene | Gel | + | + | + | + | 2019 | |
| Ciprofloxacin hydrochloride | Ointment | + | + | + | 2018 | ||
| Clindamycin phosphate | Gel | + | + | + | 2020 | ||
| Clindamycin phosphate and Tretinoin | Gel | + | + | + | 2020 | ||
| Crisaborole | Ointment | + | + | + | + | PK | 2019 |
| Crotamiton | Cream | + | 2016 | ||||
| Dapsone | Gel | + | + | + | + | PK | 2019 |
| Docosanol | Cream | + | + | + | 2017 | ||
| Doxepin hydrochloride | Cream | + | + | + | + | PK | 2019 |
| Gentamicin sulfate | Cream Ointment |
+ | 2017 | ||||
| Hydrocortisone | Cream | + | 2017 | ||||
| Ivermectin | Cream | + | + | + | + | PK | 2019 |
| Lidocaine | Ointment | + | + | 2016 | |||
| Luliconazole | Cream | + | + | + | + | 2018 | |
| Metronidazole | Gel | + | + | + | 2019 | ||
| Metronidazole | Cream | + | + | + | + | 2019 | |
| Nystatin and Triamcinolone acetonide | Cream Ointment |
+ | 2017 | ||||
| Oxymetazoline hydrochloride | Cream | + | + | + | + | 2019 | |
| Ozenoxacin | Cream | + | + | + | + | 2019 | |
| Penciclovir | Cream | + | + | + | + | 2018 | |
| Pimecrolimus | Cream | + | + | + | + | 2019 | |
| Silver sulfadiazine | Cream | + | + | + | 2017 | ||
| Tacrolimus | Ointment | + | + | + | + | 2018 | |
| Tretinoin | Gel | + | + | + | 2020 | ||
| Tretinoin | Cream | + | + | + | CES | 2020 |
+ indicates methods recommended by the guidelines; PK—in vivo pharmacokinetic study in humans; CES—clinical endpoint studies.