MITOSOL
NDA 022572 · New Drug Application (NDA) Prescription
MITOMYCIN
- Sponsor (Drugs@FDA)
- GLAUKOS Company: GLAUKOS Corp (GKOS)
- First approved
- Latest action
Drugs on HealthTrade
No drug on HealthTrade cites this application. Novel approvals since 2015 by healthcare companies HealthTrade covers are listed from Drugs@FDA automatically, labelled “Not yet reviewed”; editors link the others.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | MITOSOL MITOMYCIN | FOR SOLUTION;TOPICAL 0.2MG/VIAL | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 9 | Approved | standard | Labeling | Letter for Supplement 9 (opens in a new tab)Label for Supplement 9 (opens in a new tab) | |
| Supplement 8 | Approved | standard | Manufacturing (CMC) | Label for Supplement 8 (opens in a new tab) | |
| Supplement 5 | Approved | standard | Labeling | Letter for Supplement 5 (opens in a new tab)Label for Supplement 5 (opens in a new tab) | |
| Supplement 4 | Approved | standard | Labeling | Letter for Supplement 4 (opens in a new tab)Label for Supplement 4 (opens in a new tab) | |
| Supplement 3 | Approved | standard | Labeling | Letter for Supplement 3 (opens in a new tab)Label for Supplement 3 (opens in a new tab) | |
| Original 1 | Approved | priority | Type 3 - New Dosage Form | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
5 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 8186511Product 001 | Drug product | – | ||
| 9205075Product 001 | Drug product | – | ||
| 9539241Product 001 | Drug substance, Drug product | U-2095 | ||
| 7806265Product 001 | Drug product | – | ||
| 9649428Product 001 | Method of use | U-2095 |
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
Mitosol
MITOMYCIN · Mobius Therapeutics LLC · Version 10 · effective
Indications and usage
1 INDICATIONS AND USAGE Mitosol ® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. Mitosol ® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. ( 1 )
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 49771-002 in openFDA (opens in a new tab) | Mitosol mitomycin | Mobius Therapeutics LLC | KIT | NDA | From |
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FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-11-03.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-11-03.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-11-03.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-11-03.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.