PACLITAXEL | N020262 | HQ SPECIALTY PHARMA CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alembic Pharmaceutical Limited FDA-2021-P-1215 Alembic Pharmaceutical Limited filed this citizen petition requesting that the FDA determine whether TAXOL (paclitaxel injection, USP) 6 mg/mL, approved under NDA 020262 by HQ Specialty Pharma Corp, was withdrawn for reasons related to safety or effectiveness. The petitioner seeks a determination th | 505(q) | 2021-11-12 | Open | Alembic Pharmaceutical Limited |
Steven A. Zecola - Citizen Petition FDA-2012-P-1160 Steven A. Zecola filed this citizen petition on November 15, 2012, requesting that the FDA withdraw approval of ACT chemotherapy (Adriamycin, Cytoxan, and Taxol) as adjuvant therapy for BRCA1-related breast cancer patients, arguing that clinical trial data supporting its use in triple-negative breas | Other | 2012-12-10 | Denied | — |
Citizen Petition from Mediscovery, Inc. FDA-2006-P-0342 Mediscovery, Inc. filed this citizen petition under Section 505(j)(2)(C) of the FDC Act requesting permission to submit an abbreviated new drug application for Paclitaxel at a strength of 0.1 pM for aerosol administration, differing from the reference listed drug Taxol in both strength and route of | Other | 2008-12-12 | Open | Mediscovery, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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