FDA approved the original new drug application for ALSUMA (AUTOINJECTOR) on June 29, 2010. Today MERIDIAN MEDCL holds the application (Drugs@FDA). FDA marks the application’s only product discontinued. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA022377
- Sponsor
- MERIDIAN MEDCL
- Original approval
- Review
- standard review
- Submission class
- Type 3 - New Dosage Form
- Active ingredient
- sumatriptan succinate
Browse every approval whose brand starts with A, every approval FDA granted in 2010, or the complete response letters FDA has published — the applications it did not approve.
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Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| sumatriptan succinate EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE | SUBCUTANEOUS | Discontinued |
What “discontinued” means in FDA’s record
Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.
Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 2 · Manufacturing (CMC) 1. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-26). Every field on this page comes from that record.
An approval date is the start of the question, not the end
What comes next for the company that owns this drug is often already dated. The catalyst desk carries dated trial readouts and regulatory events for the companies it tracks, not every event in biotech. Dates are read from ClinicalTrials.gov and company filings and checked once a day, and each row names the document its date came from.
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