EPIRUBICIN HYDROCHLORIDE | A065289 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
AAC Consulting Group - CP1 FDA-2006-P-0012 AAC Consulting Group, on behalf of a client, filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA declare Epirubicin Hydrochloride Injection at 2 mg/mL in vial sizes of 10 mg/5mL, 20 mg/10mL, and 100 mg/50mL suitable for submission as an abbreviated new drug application, wi | Other | 2008-08-13 | Open | — |
AAC Consulting Group - CP1 Attachment 3 FDA-2006-P-0012 AAC Consulting Group filed this citizen petition regarding Epirubicin Hydrochloride Injection, requesting an action related to its labeling and clinical data. The petition appears to reference comprehensive clinical study information, pharmacokinetic parameters, and safety data regarding the anthrac | Other | 2008-08-13 | Open | — |
AAC Consulting Group - CP1 Attachment 2 FDA-2006-P-0012 AAC Consulting Group filed this citizen petition regarding Ellence Injection (epirubicin hydrochloride injection), a chemotherapy agent approved under an NDA for adjuvant treatment of breast cancer, and requested dosage adjustment or other regulatory action based on pharmacokinetic data showing alte | Other | 2008-08-13 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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