Prescription medicine
Alteplase Brand names: Activase, Cathflo
Alteplase (Cathflo) is a prescription medicine with an FDA approval on record since 1987. No generic is listed; pharmacies paid $186.38 per Cathflo activase 2 mg vial in the October 7, 2026 NADAC survey.
- No generic listed
- A presentation discontinued
Check it at the source: the alteplase FDA label on DailyMed (effective January 20, 2026, Genentech, Inc.); the BLA 103172 record on Drugs@FDA; every alteplase label on DailyMed.
Highlights of the record
FDA label of January 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageActivase is a tissue plasminogen activator (tPA) indicated for the treatment of: Acute Ischemic Stroke (AIS).
Forms and strengths
- 2.2 mg/2ml
Kit; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- November 13, 1987 Activase, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $186.38 per vial Cathflo activase 2 mg vial
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 2 since 2012 0 Class I among all firms' recalls; latest May 20, 2024; 2 more by firms not listed as its makers
- FAERS reports
- 14,927 through July 30, 2026
What is alteplase used for?
From the label: indications and usageActivase is a tissue plasminogen activator (tPA) indicated for the treatment of: Acute Ischemic Stroke (AIS). ( 1.1 ) Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure. ( 1.2 ) Limitation of Use in AMI: the risk of stroke may be greater than the benefit in patients at low risk of death from cardiac causes. ( 1.2 ) Acute Massive Pulmonary Embolism (PE) for lysis. ( 1.3 ) 1.1 Acute Ischemic Stroke Activase is indicated for the treatment of acute ischemic stroke. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment [see Contraindications (4.1) ]. […]
Conditions named in the indications of alteplase's FDA labels, with every medicine labeled for each:
From other alteplase labelsHeart attack and coronary artery disease: Activase is indicated for use in acute myocardial infarction (AMI) for the reduction of mortality and reduction of the incidence of heart failure.
Blood clots (DVT and PE): Activase is indicated for the lysis of acute massive pulmonary embolism, defined as:
Source: FDA drug label (Activase), Genentech, Inc., effective January 20, 2026 (SPL set c669f77c-fa48-478b-a14b-80b20a0139c2), via openFDA; the full label on DailyMed
Is there a generic for alteplase (Cathflo)?
No generic alteplase is approved (Drugs@FDA, October 8, 2026).
- 1987 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for alteplase (Cathflo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $186.38 per Cathflo activase 2 mg vial, up 5% from $177.50 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cathflo activase 2 mg vial (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cathflo activase 2 mg vial | Brand | $186.38 per vial | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is alteplase in shortage?
No alteplase presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated May 21, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Activase, Injection, 1 KIT in 1 CARTON (50242-085-27) * 100 mL in 1 VIAL, SINGLE-USE * 100 mL in 1 VIAL, SINGLE USE (NDC 50242-085-27) | Genentech, Inc | To Be Discontinued | May 21, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has alteplase been recalled?
The FDA's Enforcement Report lists 4 recalls naming alteplase since 2012: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of alteplase and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 20, 2024 | Class II | Genentech, Inc. | Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| April 12, 2019 | Class II | CMC Enterprise Pharmacy not a listed maker | Lack of sterility assurance. |
| May 25, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the alteplase label say about other medicines?
The alteplase label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name alteplase. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings and precautions | Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially at arterial puncture sites. |
| Epinephrine | warnings and precautions | If signs of hypersensitivity occur, e.g. anaphylactoid reaction or angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy (e.g., antihistamines, intravenous corticosteroids, epinephrine). |
| Heparin | warnings and precautions | Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially at arterial puncture sites. |
| Warfarin | warnings and precautions | … site Advanced age [see Use in Specific Populations (8.5) ] Patients currently receiving anticoagulants (e.g., warfarin sodium) Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location. |
Other labels that name alteplase
Source: FDA drug label (Activase), Genentech, Inc., effective January 20, 2026 (SPL set c669f77c-fa48-478b-a14b-80b20a0139c2), via openFDA; the full label on DailyMed
What do FAERS reports show for alteplase?
The FDA Adverse Event Reporting System holds 14,927 reports that list alteplase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,224 are coded as a death and 3,057 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (2,836, against a median of 849 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alteplase side effects
- the label's list beside FAERS reports
- Alteplase shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other