EPIRUBICIN HYDROCHLORIDE | N050778 | PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizens Petition from UCSF National Center of Excellence in Womens Health FDA-2005-P-0221 The UCSF National Center of Excellence in Women's Health, led by Dr. Rita F. Redberg, filed a citizens petition requesting that the FDA revise the labeling on glycoprotein IIb/IIIa inhibitors (tirofiban, lamifiban, eptifibatide, and abciximab) to reflect increased adverse event risk in women with ac | Other | 2013-05-02 | Partially Denied | UCSF National Center of Excellence in Womens Health |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.