LINACLOTIDE | A209611 | AUROBINDO PHARMA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Buchanan Ingersoll & Rooney PC ( on behalf of Synergy P... FDA-2018-P-0884 · 4 docket documents Buchanan Ingersoll & Rooney PC, on behalf of Synergy Pharmaceuticals Inc., filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA Commissioner require modification of the approved package insert for Linzess (linaclotide), NDA 202-811, to provide more complete and accessible adve | Other | 2018-02-27 | Denied | Synergy Pharmaceuticals Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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