Product: Vancocin®(vancomycin) Oral Solution
Company: Eli Lilly, ANI Pharma
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2020P-1626
Date of Petition: July 2, 2020
Responding Petitions:
Issue and Implication: Whether a discontinued product can serve as a Reference List Drug and whether old antibiotic products can…[Read more]
Product: Bactroban®(mupirocin) Nasal Ointment
Company: GlaxoSmithKline
Petition Filer: E4 Consulting
Petition Number(s): 2020P-1617
Date of Petition: June 25, 2020
Responding Petitions:
Action Requested by Petitioner: The petitioner would like to FDA to determine whether Bactroban®(mupirocin) Nasal Ointment, 2% (NDA 050703) was r…[Read more]
Product: SGLT2 Inhibitors
Company: Various
Petition Filer: Public Citizen
Petition Number(s): 2020P-1611
Date of Petition: June 24, 2020
Responding Petitions:
Issue and Implication: Whether current labeling process and labels for SGLT2 is sufficient to ensure safe and effective prescribing.
Action Requested by Petitioner: The…[Read more]
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