Report highlights approvals, challenges and deals in the generics sector

9 June 2014

India-based groups received the most approvals for Abbreviated New Drug Applications from the US Food and Drug Administration in the first quarter of 2014, according to the Thomson Reuters Newport Premium Movers & Shakers quarterly report of the trends and statistics in the US generics industry.

Approvals

The report found that 49 companies from nine countries received a total of 103 final ANDA approvals, but India-based groups received the most approvals, with 41 approvals granted among 14 corporate groups. USA-based companies followed, with 26 corporate groups receiving a total of 40 approvals. In comparison, during the fourth quarter of 2013, 42 companies from 11 countries received a total of 90 final ANDA approvals, with 41 approvals going to 16 corporate groups from India, and 29 approvals going to 14 groups from the USA. During the first quarter of 2014, US generic drugmaker Mylan (Nasdaq: MYL) led the field, receiving eight final ANDA approvals. Indian pharma major Lupin (BSE: 500257) and Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) were next in line with seven approvals each.

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