Purdue Files ANDA Amid Global Bankruptcy Settlement Bid

Company Seeking To Become ‘Public Health Company’

11 Jun 2021

Purdue Pharma has taken a step in its bid to develop and market generic versions of treatments to reverse opioid overdose “at or below cost,” following its filing for bankruptcy.

An ampoule Opioid next to it is a note written in English Opioid epidemic. All around, many tablets and syringes are scattered. — Purdue has priority review for nalmefene • Source: Shutterstock

Disgraced former opioids manufacturer Purdue Pharma says its abbreviated new drug application for the vial dosage form of nalmefene hydrochloride injection designed to reverse opioid overdose has been accepted for filing by the US Food and Drug Administration.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Lupin Touts FDA Approval For Generic Tolvaptan With 180-Day Exclusivity

02 May 2025

• By Urtė Fultinavičiūtė

After receiving a favorable court ruling last year, Lupin has secured its first-place spot for generic tolvaptan tablets in the US.

BGMA Becomes Medicines UK

01 May 2025

• By Dave Wallace

The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

01 May 2025

• By Dean Rudge

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

Iconovo Slims Down As It Focuses On Commercialization

29 Apr 2025

• By Dave Wallace

As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.

J&J Denied Injunction Over Private-Label Ustekinumab In US

01 May 2025

• By Dave Wallace

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.