USFDA seeks additional data in Biocon's application for Insulin-R

The US Food and Drug Administration (USFDA) has issued a complete response letter to Biocon Ltd seeking additional data in the company's licence application for the Insulin-R product, the pharma company said in an exchange filing today.

The reply letter included a statement that a corrective and preventive action plan for the pre-approval inspection of Biocon's facilities in Bengaluru was expected to be satisfactorily implemented.

After evaluating Biocon's seven manufacturing facilities spread over two sites in Bengaluru and one site in Malaysia, the federal agency issued Form 483 with numerous observations in August.

In these facilities, the company produces biosimilar medications such Bevacizumab, rh-Insulin, and Insulin Aspart.

FPJ Shorts

Mumbai News: BMC Puts Prime 23,822 Sq m Lower Parel Land Parcel On Lease After Supreme Court Win; Expects ₹1,348 Crore Revenue

Bombay HC Grants Bail To Alleged LeT Operative Accused Of 2010 Nashik Reconnaissance Case; Cites Over 10 Years In Jail And Trial Delays

Bombay HC: Magistrate Cannot Order Blocking Of Online Content Under IT Act; Upholds Stay On Contempt Plea Against Google

Bombay HC Cancels Bail Of Stepfather Accused Of Raping Minor For 2 Years; Calls Lower Court Order ‘Unreasonable’, Orders Immediate Arrest

According to the company's filing, Biocon is currently working to respond fully to the US Food and Drug Administration's response letter.

Read Also

Alembic Pharma gets USFDA approval for drug to treat overactive bladder