PACLITAXEL | N020262 | HQ SPECIALTY PHARMA CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alembic Pharmaceutical Limited FDA-2021-P-1215 · 4 docket documents 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determine whether TAXOL (paclitaxel injection, USP) 6 mg/mL, approved under NDA 020262 by HQ Specialty Pharma Corp, was withdrawn for reasons related to safety or effectiveness.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 · 4 docket documents 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 · 3 docket documents 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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