PREGABALIN | N022488 | UPJOHN US 2 LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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for R-isomer impurity, and refuse to accept amendments to such specifications | 505(q) Stay Request | 2012-06-01 | Withdrawn | — |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.
Highest NADAC/Unit
$0.1553
per ml
Lowest NADAC/Unit
$0.1553
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59762157601PREGABALIN 20 MG/ML SOLUTION | $0.1553 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.