AstraZeneca Pharma gets CSDCO nod to import anti-cancer drug Lynparza
In a regulatory filing, the company said it has received permission from the Central Drugs Standard Control Organisation (CSDCO), Directorate General of Health Services, Government of India, to import for sale and distribution of Olaparib film-coated Tablets 100 mg and 150 mg (Lynparza).
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AstraZeneca Pharma India Ltd on Tuesday said it has received approval from the Indian drug regulator for the import for sale and distribution of cancer treatment drug Lynparza.
In a regulatory filing, the company said it has received permission from the Central Drugs Standard Control Organisation (CSDCO), Directorate General of Health Services, Government of India, to import for sale and distribution of Olaparib film-coated Tablets 100 mg and 150 mg (Lynparza).
Olaparib in combination with Durvalumab is indicated for the maintenance treatment of adult patients with advanced or recurrent endometrial cancer whose disease has not progressed on first-line treatment with Durvalumab in combination with platinum-based chemotherapy, it said.
"The receipt of this permission paves way for the launch of Olaparib film-coated tablets 100 mg and 150 mg (Lynparza) in India for the above specified additional indication, subject to the receipt of related statutory approvals...," the company added.
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