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Research Criteria and Technical Notes

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Latest updates

Product: Ketorolac Tromethamine Tablets
Company: Teva, Mylan, various
Petition Filer: Fox Rothschild, a law firm
Petition Number(s): 2020P-0745
Date of Petition: February 12, 2020
Responding Petitions:

Issue and Implication: Whether FDA must designate a second Reference Standard.

Action Requested by Petitioner: Petitioner is…[Read more]

Profile picture of gregoryglass 4 days, 16 hours ago

Product: Erectile Dysfunction Drugs (Cialis® (tadalafil), Levitra® (vardenafil), Viagra®(sildenafil))
Company: Eli Lilly, Bayer, Pfizer and various
Petition Filer: Physicians for Responsible Medicine
Petition Number(s): 2020P-0698
Date of Petition: February 10, 2020
Responding Petitions:

Issue and Implication: Whether the class la…[Read more]

Profile picture of gregoryglass 6 days, 13 hours ago

Product: Dextrose in Plastic Containers
Company: Baxter Pharmaceuticals
Petition Filer: Fresenius Kabi
Petition Number(s): 2020P-0678
Date of Petition: February 7, 2020
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Dextrose, 70gm/100mL (NDA 017521) was removed for…[Read more]

Profile picture of gregoryglass 1 week ago
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