FDA approves Boehringer and Lilly's Tradjenta and Jentadueto labeling to reflect pancreatitis risk

21 June 2013

German family-owned Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY) revealed yesterday (June 20) that the US Food and Drug Administration has approved updates to the full prescribing information (PI) for their diabetes drugs Tradjenta (linagliptin) and Jentadueto (linagliptin and metformin hydrochloride) tablets.

These updates are part of ongoing efforts to update product labels to ensure physicians, pharmacists and patients have the information they need to use the medications appropriately. Information about pancreatitis was included in the adverse reactions sections of the original labels for these products; it is now displayed in additional sections of the PIs, the companies said in a joint statement.

The updates are the same for both products, and include the following changes to the respective PIs:

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK