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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
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
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
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Latest updates
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
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
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
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Latest updates
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
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
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
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Latest updates
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
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
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