Drugplain

SKYCLARYS 50 mg/1

omaveloxolone · CAPSULE · Biogen

No Recall History
Plain English

Skyclarys (omaveloxolone) is an oral capsule medication used to treat Friedreich's ataxia, a rare inherited neurological disorder that affects movement and coordination. It works by activating certain cellular pathways that help protect nerve cells from damage.

Key Facts

Brand Name
SKYCLARYS
Generic Name
omaveloxolone
NDC Code (Product)
64406-250
Manufacturer
Biogen
Strength
50 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
NDA216718
Drug Class
Cytochrome P450 3A4 Inducers [MoA]; Cytochrome P450 2C8 Inducers [MoA]
Marketing Start
02/28/2023

Recall History

No Recall History

Frequently Asked Questions

What is SKYCLARYS used for?

Skyclarys (omaveloxolone) is an oral capsule medication used to treat Friedreich's ataxia, a rare inherited neurological disorder that affects movement and coordination. It works by activating certain cellular pathways that help protect nerve cells from damage.

Is SKYCLARYS a controlled substance?

SKYCLARYS is not classified as a controlled substance by the DEA.

What is the generic name for SKYCLARYS?

The generic name for SKYCLARYS is omaveloxolone. There are no other listed brand versions of omaveloxolone.

What is the NDC code for SKYCLARYS 50 mg/1?

The NDC (National Drug Code) for SKYCLARYS 50 mg/1 is 64406-250, listed by Biogen.

Product NDC

64406-250

Package NDC

64406-250-90

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)