By: IPP Bureau
Last updated : November 23, 2023 6:05 am
The receipt of this permission paves way for the launch of Olaparib film coated tablets in India
AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from Central Drugs Standard Control Organisation for the additional indication of Olaparib film coated tablets of 100mg / 150mg (Lynparza).
Through this approval, Olaparib film coated tablets of 100mg/150mg (Lynparza) in combination with Abiraterone and Prednisone or Prednisolone is indicated for the treatment of adult patients with metastatic castration - resistant prostate cancer.
The receipt of this permission paves way for the launch of Olaparib film coated tablets of 100mg / 150mg (Lynparza) in India for the above specified additional indication, subject to the receipt of related statutory approvals, if any.
While the aforementioned permission was received end of business hours on November 17, 2023, some time was spent in good faith for evaluation of the contents and conditions laid by the regulator in the permission.