SUMATRIPTAN | N210884 | TONIX MEDICINES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alexander Mauskop FDA-2026-P-0925 Alexander Mauskop filed this citizen petition in January 2026 requesting that the FDA amend the prescription status of seven triptan medications—sumatriptan, naratriptan, rizatriptan, eletriptan, zolmitriptan, almotriptan, and frovatriptan—to allow their availability as over-the-counter products by | Other | 2026-01-30 | Open | Alexander Mauskop |
Attachment 2 - IMITREX- sumatriptan tablet, film coated RE Suitability Petiti... FDA-2023-P-4784 Hyman, Phelps & McNamara, P.C. filed a citizen petition regarding IMITREX (sumatriptan tablet, film coated) requesting a determination of suitability, likely under 21 CFR 314.80 or related regulatory provisions governing the appropriateness of the drug product formulation or manufacturing process fo | Suitability | 2023-10-30 | Denied | Hyman, Phelps & McNamara, P.C. |
Attachment 3 - Sumatriptan oral solution RE Suitability Petition from Hyman, ... FDA-2023-P-4784 Hyman, Phelps & McNamara, P.C. filed a petition regarding the suitability of sumatriptan oral solution, requesting that the FDA make a determination about whether this formulation is appropriate for development and approval as a drug product under the NDA or ANDA pathway. | Suitability | 2023-10-30 | Denied | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$108.16
per ea
Lowest NADAC/Unit
$108.16
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00245081261TOSYMRA 10 MG NASAL SPRAY | $108.16 | EA | Brand | — | 2026-10-21 |
| 70792081261TOSYMRA 10 MG NASAL SPRAY | $108.16 | EA | Brand | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.