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Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.
Manufacturer / Innovator:
USA
Regulatory Approval:
N/A
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Skyclarys (omaveloxolone) is approved by the FDA for the treatment of Friedreich's ataxia in adults and adolescents 16 years of age and older. It was the first therapy ever approved specifically for this rare, progressive genetic disease.
Skyclarys activates the Nrf2 pathway, a cellular defense mechanism that helps regulate antioxidant and anti-inflammatory responses. In Friedreich's ataxia, this pathway is often impaired; by activating Nrf2, Skyclarys is thought to help protect cells from the oxidative stress and mitochondrial dysfunction underlying the disease.
Skyclarys is intended for patients diagnosed with Friedreich's ataxia who are 16 years of age or older, a population previously without any FDA-approved treatment specifically targeting the disease.
The recommended dose of Skyclarys is 150 mg (three 50 mg capsules) taken orally once daily on an empty stomach, at least one hour before or two hours after eating.
Skyclarys does not carry a formal FDA boxed warning. However, patients and prescribers should be aware of the following important safety information.
Elevations in ALT, AST, and bilirubin have been observed. Liver function tests should be monitored at baseline and monthly for the first three months of treatment.
Increases in B-type natriuretic peptide, which may indicate fluid overload, have been reported. Patients should be monitored for relevant signs and symptoms.
Changes in cholesterol levels have been observed. Periodic lipid monitoring is recommended during treatment.
Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.
Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.
Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.
Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.
Skyclarys is manufactured and marketed by Biogen. It is sourced through authorized distribution channels for patients seeking named-patient import into India.
Patients typically need a valid prescription from a treating neurologist confirming a diagnosis of Friedreich's ataxia. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As the first FDA-approved therapy for Friedreich's ataxia, Skyclarys is sourced through authorized channels and imported under GDP-compliant logistics to preserve product quality throughout transit.
NPP sources Skyclarys directly from authorized pharmaceutical distributors to ensure product authenticity and full traceability. Every shipment is handled under Good Distribution Practice (GDP) conditions from origin to the patient's doorstep.
Skyclarys should be stored at 20°C to 25°C, with excursions permitted between 15°C and 30°C, and this condition is maintained throughout transit.
Once documentation and regulatory approvals are in place, delivery timelines are communicated transparently at the time of quotation, accounting for import clearance and last-mile logistics to the patient's city.
Patients across India can access Skyclarys through NPP's regulated import pathway, with neurology specialists in major cities supporting the treatment process.
Leading hospitals in Mumbai support neurology care coordination and documentation for Skyclarys access.
Delhi's major hospitals assist patients with prescription support and documentation for Skyclarys.
Bangalore's specialist network offers access coordination for eligible Friedreich's ataxia patients seeking Skyclarys.
Chennai-based neurology specialists coordinate Skyclarys access alongside comprehensive ataxia care.
Hyderabad's care institutions support patients pursuing Skyclarys therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Skyclarys.
Pune-based specialists assist with prescription support and Skyclarys treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Skyclarys.
Kochi's specialist units assist patients with the documentation needed for Skyclarys access.
Chandigarh's care centers support Skyclarys treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Skyclarys access process.
Lucknow-based centers assist patients pursuing Skyclarys therapy.
Bhubaneswar's institutions support access to Skyclarys for eligible patients.
Guwahati's specialists help coordinate Skyclarys access for patients across the Northeast.
Patients in other cities across India can also access Skyclarys through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 15 September 2026
Sources: FDA
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 15 September 2026
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