Prescription medicine
Pasireotide Brand names: Signifor; first approved as Signifor Lar
Pasireotide (Signifor) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pasireotide FDA label on DailyMed (effective July 16, 2024, Recordati Rare Diseases, Inc.); the NDA 203255 record on Drugs@FDA; every pasireotide label on DailyMed.
Highlights of the record
FDA label of July 16, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSIGNIFOR LAR is a somatostatin analog indicated for the treatment of: Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
Forms and strengths
- 0.3 mg/ml
- 0.6 mg/ml
- 0.9 mg/ml
Kit; injection.
On the market
- Earliest approval on file
- December 15, 2014 Signifor Lar Kit, Recordati Rare; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- Last listed patent
- May 23, 2028 Signifor Lar Kit injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,235 through July 30, 2026
What is pasireotide used for?
From the label: indications and usageSIGNIFOR LAR is a somatostatin analog indicated for the treatment of: Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. ( 1.1 ) Patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. ( 1.2 ) 1.1 Acromegaly SIGNIFOR LAR is indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. 1.2 Cushing's Disease SIGNIFOR LAR is indicated for the treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.
FDA pharmacologic class: Somatostatin Analog.
Source: FDA drug label (Signifor LAR), Recordati Rare Diseases, Inc., effective July 16, 2024 (SPL set a0aad470-3f38-af97-e053-2995a90a383a), via openFDA; the full label on DailyMed
Is there a generic for pasireotide (Signifor)?
No generic pasireotide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Signifor Lar Kit injection: the compound patent runs to December 14, 2026, and the last listed entry to May 23, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the pasireotide label say about other medicines?
The pasireotide label names 2 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Bromocriptine | drug interactions | Consider additional monitoring. ( 7.2 ) Bromocriptine: Consider bromocriptine dose reduction. |
| Cyclosporine | drug interactions | Concomitant administration of cyclosporine with SIGNIFOR LAR may decrease the relative bioavailability of cyclosporine and, therefore, dose adjustment of cyclosporine to maintain therapeutic levels may be necessary. |
Source: FDA drug label (Signifor LAR), Recordati Rare Diseases, Inc., effective July 16, 2024 (SPL set a0aad470-3f38-af97-e053-2995a90a383a), via openFDA; the full label on DailyMed
What do FAERS reports show for pasireotide?
The FDA Adverse Event Reporting System holds 2,235 reports that list pasireotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 157 are coded as a death and 641 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 received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other somatostatin analogs
- the pharmacologic class, with prices and generics
- Pasireotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other