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Research Criteria and Technical Notes

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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

Profile picture of gregoryglass 3 days, 6 hours ago

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

Profile picture of gregoryglass 1 week, 5 days ago

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

Profile picture of gregoryglass 2 weeks, 2 days ago
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