Prescription medicine
Palovarotene Brand names: Sohonos
Palovarotene (Sohonos) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the palovarotene FDA label on DailyMed (effective August 31, 2026, Ipsen Biopharmaceuticals, Inc.); the NDA 215559 record on Drugs@FDA; every palovarotene label on DailyMed.
Highlights of the record
FDA label of August 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL.
TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN GROWING PEDIATRIC PATIENTS WARNING: EMBRYO-FETAL TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN GROWING PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. SOHONOS is contraindicated in pregnancy ( 5.1 , 8.1 ) Because of the risk of teratogenicity and to minimize fetal exposure, SOHONOS is to be administered only if conditions for pregnancy prevention are met ( 5.1 , 8.1 ) SOHONOS causes premature epiphyseal closure in growing pediatric patients with FOP, close monitoring is recommended ( 5.2 , 8.4 ) Embryo-Fetal Toxicity SOHONOS is contraindicated in pregnancy. SOHONOS may cause fetal harm. Because of the risk of teratogenicity and to minimize fetal exposure, SOHONOS is to be administered only if conditions for pregnancy prevention are met [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Premature Epiphyseal Closure Premature epiphyseal closure occurs in growing pediatric patients treated with SOHONOS, close monitoring is recommended [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4) ].
Used for
From the label: indications and usageSOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).
Forms and strengths
- 1 mg
- 1.5 mg
- 2.5 mg
- 5 mg
- 10 mg
Capsule.
On the market
- Earliest approval on file
- August 16, 2023 Sohonos, Ipsen; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- June 8, 2037 Sohonos capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- No recall recorded
What is palovarotene used for?
From the label: indications and usageSOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP). SOHONOS is a retinoid indicated for reduction in the volume of new heterotopic ossification in adults and children aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP) ( 1 ).
FDA pharmacologic class: Retinoid.
Source: FDA drug label (SOHONOS), Ipsen Biopharmaceuticals, Inc., effective August 31, 2026 (SPL set 67dce406-7cc4-4d66-92de-ad18b6df0625), via openFDA; the full label on DailyMed
What does the patient leaflet for palovarotene say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SOHONOS?SOHONOS can cause birth defects (deformed babies) if taken during pregnancy. Females who are pregnant or who plan to become pregnant must not take SOHONOS. Females who can become pregnant: - Your healthcare provider will ask you to take a pregnancy test 1 week before starting treatment with SOHONOS, periodically during treatment, and 1 month after you stop treatment with SOHONOS. - You must use effective birth control (contraception) starting at least 1 month before starting treatment with SOHONOS, during treatment and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you. - If you become pregnant or think you may be pregnant during treatment with SOHONOS, stop taking SOHONOS and call your healthcare provider right away. Because SOHONOS can cause birth defects, SOHONOS is only for people who can understand and agree to carry out all instructions for pregnancy prevention. SOHONOS can cause bone growth changes. Children may stop growing while taking SOHONOS. Bone growth changes such as permanent early closure of the growth plate in growing children have happened with SOHONOS. Your healthcare provider will closely monitor your child's bone growth and height during treatment with SOHONOS.
From the patient leaflet: What should I avoid while taking SOHONOS?Do not get pregnant while taking SOHONOS. See " What is the most important Information I should know about SOHONOS? " Avoid excessive exposure to sunlight and ultraviolet lights (e.g., tanning machines). SOHONOS may make your skin more sensitive to sunlight and ultraviolet light and you may burn more easily. You should use sunscreen and wear sunglasses and protective clothing that covers your skin to help protect against sunburn if you must be in the sunlight during treatment with SOHONOS. Avoid driving at night until you know if SOHONOS has affected your vision. SOHONOS may decrease your ability to see in the dark. Do not donate blood while taking SOHONOS and for 1 week after stopping SOHONOS.
From the patient leaflet: How should I store SOHONOS?Store SOHONOS at room temperature between 68° to 77°F (20° to 25°C) in the original carton to protect from light. Keep SOHONOS and all medicines out of the reach of children.
Source: FDA drug label (SOHONOS), Ipsen Biopharmaceuticals, Inc., effective August 31, 2026 (SPL set 67dce406-7cc4-4d66-92de-ad18b6df0625), via openFDA; the full label on DailyMed
Is there a generic for palovarotene (Sohonos)?
No generic palovarotene is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Sohonos capsules, the last expiring on June 8, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is palovarotene in shortage?
No palovarotene 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 August 31, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| SOHONOS, Capsule, 2.5 mg (NDC 15054-0025-1) | Ipsen Biopharmaceuticals, Inc. | To Be Discontinued | August 31, 2026 |
Every palovarotene presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the palovarotene label say about other medicines?
The palovarotene 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 |
|---|---|---|
| Prednisone | drug interactions | … (6.1) ]. No clinically significant drug-drug interaction is expected when SOHONOS is co-administered with prednisone [see Clinical Pharmacology (12.3) ]. |
| Vitamin a | drug interactions | Avoid concomitant use of strong/moderate CYP3A4 inducers ( 7.1 ) Vitamin A: May cause additive effects ( 7.2 ) Tetracyclines: |
Source: FDA drug label (SOHONOS), Ipsen Biopharmaceuticals, Inc., effective August 31, 2026 (SPL set 67dce406-7cc4-4d66-92de-ad18b6df0625), via openFDA; the full label on DailyMed
What next?
- Other retinoids
- the pharmacologic class, with prices and generics
- Palovarotene shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other