AZ halts Dr Reddy’s ‘purple pill’ generic; firm responds to FDA Letter
AstraZeneca objects to Dr Reddy’s using the same colour as AZ’s product – which it markets as the “purple pill.”
The ban takes effect immediately and prevents Dr Reddy’s from selling, distributing or transferring the acid reflux medicine.
Dr Reddy’s issued a statement saying it is obeying the order pending a further hearing or trial. The court has set a phone conference on November 12.
Warning letter: 15 days to reform
Dr Reddy’s executives also updated investors late last Friday on the US FDA Warning Letter it received regarding three API and formulation sites in India.
CEO GV Prasad revealed the company has brought in third-party assessors to review its quality systems and global manufacturing operations.
In the meantime, the Dr Reddy’s is transferring some of its manufacturing from the troubled facilities in Srikakulum, Miryalaguda and Duvvada to alternate sites. Because of the time and effort, the company will “prioritise select products” for transfer. There is no FDA directive to stop manufacturing or shipment, he said.
Prasad avoided addressing any specific observations made by the FDA, but said the problems were GMP violations relating “primarily to documentation practices and controls, laboratory testing procedures, incident investigation practices, as well as some standard operating procedures.”
The FDA gave Dr Reddy’s a deadline of 15 days from Friday, November 9 to reform: “Until the matter is resolved, the agency may withhold approval of any new applications which involve these sites,” said Prasad.
