IRON SUCROSE | N021135 | AMERICAN REGENT INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sidley Austin LLP on behalf of Vifor Pharma FDA-2020-P-0158 Sidley Austin LLP, on behalf of Vifor Pharma, filed this citizen petition in January 2020 requesting that the FDA clarify that the ANDA pathway under Section 505(j) is inappropriate for follow-on harder-to-copy complex drugs and that approvals for such drugs must instead proceed under Section 505(b) | 505(q) | 2020-01-10 | Open | Vifor Pharma |
Navinta, LLC - Citizen Petition FDA-2011-P-0087 Navinta LLC filed this citizen petition on February 9, 2011, requesting that the FDA refrain from approving any pending or new applications submitted under 505(j) or 505(b)(2) for Iron Sucrose Injection products that do not demonstrate pharmaceutical equivalence to the reference listed drug Venofer | 505(q) | 2011-02-18 | Denied | — |
Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath & Rosenthal, LLP) - Citize... FDA-2005-P-0319 Luitpold Pharmaceuticals, Inc., filed this citizen petition on March 3, 2005, requesting that the FDA withhold approval of any Abbreviated New Drug Application (ANDA) or 505(b)(2) application for generic versions or pharmaceutical alternatives of VENOFER (iron sucrose injection, USP) unless applican | 505(q) | 2010-05-14 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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