India's Lupin gets two generics approvals from FDA

4 July 2023
lupin-big

Mumbai, India-based generic drugmaker Lupin Limited (BSE: 500257) saw US regulatory approval for two of its copy medicines in the space of two days.

Today, Lupin announced that it has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) on dolutegravir tablets for oral suspension, 5mg, to market a generic equivalent of HIV drug Tivicay PD tablets for oral suspension, 5mg of ViiV Healthcare, which is majority owned by UK pharma major GSK (LSE: GSK).

This product will be manufactured at Lupin’s Nagpur facility in India.

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.

Login to your account

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

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Generics