CYCLOSPORINE | N050790 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Allergan FDA-2017-P-4745 · 23 docket documents Allergan filed this citizen petition under 21 U.S.C. § 355 requesting that FDA refuse to approve any ANDA for cyclosporine ophthalmic emulsion that references RESTASIS (NDA 050790) as the reference listed drug unless the applicant relies on appropriately designed clinical endpoint bioequivalence stu | 505(q) | 2017-08-08 | Denied | Allergan |
Citizen Petition from Physical Pharmaceutica, LLC FDA-2015-P-1404 · 4 docket documents Physical Pharmaceutica LLC filed this citizen petition in April 2015 regarding the approval of Abbreviated New Drug Applications (ANDAs) referencing RESTASIS 0.05% ophthalmic emulsion as the reference listed drug. Physical Pharmaceutica requests that the FDA provide detailed guidance on what compara | 505(q) | 2015-04-30 | Partially Denied | Physical Pharmaceutica, LLC |
Citizen Petition From Allergan, Inc. FDA-2015-P-0065 · 25 docket documents Allergan, Inc. filed this citizen petition on December 23, 2014, requesting that FDA refuse to receive for substantive review or approve any abbreviated new drug application referencing RESTASIS (cyclosporine ophthalmic emulsion) unless it includes data from comparative clinical trials demonstrating | 505(q) | 2015-01-16 | Partially Denied | Allergan, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$112.33
per ea
Lowest NADAC/Unit
$1.08
per ea
Brand NDCs
3
Generic NDCs
6
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00023530105RESTASIS MULTIDOSE 0.05% EYE | $112.33 | ML | Brand | — | 2026-06-17 |
| 00023916360RESTASIS 0.05% EYE EMULSION | $10.32 | EA | Brand | $1.08 | 2026-06-17 |
| 00023916330RESTASIS 0.05% EYE EMULSION | $10.32 | EA | Brand | $1.32 | 2026-06-17 |
| 60505620201CYCLOSPORINE 0.05% EYE EMULSION | $1.32 | EA | Generic | — | 2026-06-17 |
| 68180021430CYCLOSPORINE 0.05% EYE EMULSION | $1.32 | EA | Generic | — | 2026-06-17 |
| 10702080803CYCLOSPORINE 0.05% EYE EMULSION | $1.32 | EA | Generic | — | 2026-06-17 |
Showing 6 of 9 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.