Cancer drug: AstraZeneca Pharma India bags CSDCO permission to import Lynparza

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-11-26T15:54:12+05:30 | Updated On 26 Nov 2024 3:54 PM IST

CDSCO panel grants clearance to Morepen Labs to conduct BE studies for fatty liver disease drug

Bangalore: AstraZeneca Pharma India Limited has received permission to import for sale and distribution in Form CT-20 from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India for the additional indication of Olaparib film-coated Tablets 100 mg & 150 mg (Lynparza).

Through this approval, 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.

The receipt of this permission paves way for the launch of Olaparib film-coated Tablets 100 mg & 150 mg (Lynparza) in India for the above specified additional indication, subject to the receipt of related statutory approvals, if any.

Medical dialogues team had earlier reported that the company had also received permission to import for sale and distribution of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India for an additional indication, subject to the receipt of related statutory approvals, if any. Durvalumab in combination with chemotherapy as neoadjuvant treatment, followed by Durvalumab as monotherapy after surgery, is indicated for the treatment of patients with resectable (tumours 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Read also: AstraZeneca, Daiichi Sankyo submits Datopotamab deruxtecan new BLA for accelerated approval in US for lung cancer

Established in 1979, the Company is headquartered at Bengaluru, Karnataka in India and has a workforce of over 800 employees across the country.

astrazeneca pharma indiaCDSCOOlaparib film coated TabletsLynparzaDurvalumabendometrial cancer

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751