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Gregory Glass

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Gregory Glass
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gregoryglass

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@gregoryglass

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Product: Votrient®(pazopanib) Tablets
Company: Novartis
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2021P-0271
Date of Petition: March 5, 2021
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Votrient®(pazopanib) Tablets (NDA 022465), 400mg, was removed f…Read more

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Product: Zepzelca®(lurbinectedin) Injection
Company: Pharma Mar
Petition Filer: Foley Hoag, a law firm
Petition Number(s): 2020P-0268
Date of Petition: March 5, 2021
Responding Petitions:

Issue and Implication: Whether an adverse, post-marketing clinical study merits the removal of a product approved on an accelerated…Read more

Profile picture of gregoryglass 2 days, 9 hours ago

Product: Avaclyr®(acyclovir) Ophthalmic Ointment
Company: Fera Pharmaceuticals
Petition Filer: Cumulus Pharmaceutical
Petition Number(s): 2021P-0226
Date of Petition: February 24, 2021
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Avaclyr®(acyclovir) Ophthalmic O…Read more

Profile picture of gregoryglass 1 week, 4 days ago
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