Drug firm AstraZeneca Pharma India on Sunday said it has received import and market permission from the Indian drug regulator for Selumetinib capsules.
The company has received the import and market permission in Form CT-20 from the Drugs Controller General of India for Selumetinib 10 mg & 25 mg capsules, AstraZeneca Pharma India said in a regulatory filing.
The receipt of this permission paves way for the launch of Selumetinib 10 mg & 25 mg capsules in India, subject to the receipt of related statutory approvals and licenses, it added.
Selumetinib 10 mg & 25 mg capsules are indicated for treatment of pediatric patients 3 years of age and older with neurofibromatosis type 1 and who have symptomatic, inoperable plexiform neurofibromas, it added.
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