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May 24, 2024
DCGI orders withdrawal of AstraZeneca's Olaparib tablets for gBRCA mutation and advanced ovarian cancer due to potential adverse effects. The drug was
May 23, 2024
The communication stated that the firm presented the clinical evidence for the withdrawal of indication of Olaparib tablets.
May 23, 2024
Cgi orders withdrawal of cancer drug olaparib for certain treatments
May 22, 2024
Get latest articles and stories on India at LatestLY. The Drug Controller General of India has asked drug regulators in all states and Union territories to withdraw AstraZeneca's anti-cancer drug Olaparib tablets for treatment in patients who have received three or more prior lines of chemotherapy. India News | DCGI Orders Withdrawal of Cancer Drug Olaparib for Certain Treatments.
May 22, 2024
Indias DCGI orders the withdrawal of Olaparib for specific cancer treatments after reviewing adverse effects and survival data.
February 13, 2023
Natco Pharma on Monday said it has submitted a new application with the US health regulator for marketing authorisation of the generic version of Olaparib tablets, used in treating certain forms of ovarian, breast, pancreatic and prostate cancers, via an exchange filing. The company has submitted an Abbreviated New Drug Application (ANDA) containing a 'paragraph IV'
February 13, 2023
NATCO Pharma Ltd announces submission of Abbreviated New Drug Application containing a paragraph IV certification with the U.S. Food and Drug Administration for the generic version of Olaparib Tablets 100mg and 150mg.