AstraZeneca Pharma India gets DCGI nod to import, market Selumetinib

PTI New Delhi | Updated on September 27, 2021

Permission paves the way for launch of 10 and 25 mg capsules in India

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.

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The receipt of this permission paves the way for the launch of Selumetinib 10 mg & 25 mg capsules in India, subject to the receipt of related statutory approvals and licences, it added.

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Selumetinib 10 mg & 25 mg capsules are indicated for treatment of paediatric patients three years of age and older with neurofibromatosis type 1 and who have symptomatic, inoperable plexiform neurofibromas, it added.’

Published on September 27, 2021

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