palovarotene
Drug Details
- Generic Name
- palovarotene
- Brand Names
- SOHONOS
- Application Number
- NDA215559
- Sponsor
- Ipsen Biopharmaceuticals, Inc.
- NDC Codes
- 6
- Dosage Forms
- CAPSULE, POWDER
- Routes
- ORAL
- Active Ingredients
- PALOVAROTENE
Indications and Usage
1 INDICATIONS AND USAGE SOHONOS 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 ).