PREGABALIN | N209501 | UPJOHN US 2 LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from PharmaVector LLC FDA-2026-P-1792 · 7 docket documents PharmaVector LLC filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA declaration that Pregabalin Extended-Release Tablets in 247.5 mg, 495 mg and 660 mg strengths are suitable for submission as an ANDA, with LYRICA CR Extended-Re | Suitability | 2026-02-19 | Granted | PharmaVector LLC |
Pfizer, Inc. - Citizen Petition FDA-2012-P-0583 · 6 docket documents Pfizer Inc filed this citizen petition under 21 U.S.C. 351 and 355 requesting that the FDA Commissioner refuse to approve any abbreviated new drug applications referencing Pfizer's Lyrica (pregabalin) that contain a minimum level specification for R-isomer impurity, refuse to accept amendments chang | 505(q) | 2012-06-08 | Partially Denied | — |
Pfizer Inc - Citizen Petition FDA-2012-P-0545 · 3 docket documents Pfizer Inc filed this citizen petition under 21 U.S.C. 355(j) requesting that FDA refuse to approve any abbreviated new drug applications referencing Lyrica (pregabalin) that contain a "not less than" minimum specification for R-isomer impurity, and refuse to accept amendments to such specifications | 505(q) Stay Request | 2012-06-01 | Withdrawn | — |
Sandoz, Inc. - Citizen Petition FDA-2010-P-0087 · 4 docket documents Sandoz Inc. filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any ANDA for generic pregabalin capsules if the proposed labeling omits or carves out either the seizure indication or pain indications of LYRICA, argu | 505(q) | 2010-02-22 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.