Product: Duobrii®(halobetasol and tazarotene) Lotion
Company: Bausch Health
Petition Filer: Bausch Health
Petition Number(s): 2021P-0550
Date of Petition: June 16, 2021
Responding Petitions:
Issue and Implication: Whether current bioequivalence standards are sufficient to ensure product sameness and efficacy.
Action Requested…Read more
Product: Upneeq®(oxymetazoline) Ophthalmic Solution
Company: RVL Pharmaceuticals
Petition Filer: RVL Pharmaceuticals
Petition Number(s): 2021P-0533
Date of Petition: June 7, 2021
Responding Petitions:
Issue and Implication: Whether current FDA bioquivalence standards are sufficient to ensure product sameness with ANDA and…Read more
Product: Xhance®(fluticasone) Nasal Spray
Company: OptiNose
Petition Filer: OptiNose
Petition Number(s): 2021P-0530
Date of Petition: June 3, 2021
Responding Petitions:
Issue and Implication: Whether current FDA standards are sufficient to ensure bioequivalence of a drug-device combination product.
Action Requested by…Read more
.
