AstraZeneca Pharma India Limited has received Import and Market Permission in Form CT-20 from the Drugs Controller General of India for Selumetinib 10 mg & 25 mg capsule.
Selumetinib can also cause cardiomyopathy, ocular toxicity including retinal vein occlusion, retinal pigment epithelial detachment and impaired vision, and increased creatinine phosphokinase. Selumetinib should be withheld, dosage reduced, or permanently discontinued based on the severity of adverse reactions.
Selumetinib 10 mg & 25 mg capsule is indicated for treatment of Pediatric patients 3 years of age and older with neurofibromatosis type 1 (NF1) and who have symptomatic, inoperable plexiform neurofibromas (PN).
The receipt of this permission paves way for the launch of Selumetinib 10 mg & 25 mg capsule in India, subject to the receipt of related statutory approvals and licenses.
On April 2020, the Food and Drug Administration approved selumetinib for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. Selumetinib, a kinase inhibitor, is the first therapy approved for pediatric patients who have this debilitating, and often disfiguring, rare disease.
