CDER's Woodcock suggests exclusivity rules outdated for abuse-deterrent technology development, and Rep. Griffith takes it to mean legal changes are needed.
Rx product exclusivity laws, as they relate to abuse-deterrent formulations of pain treatments, seem ripe for adjustment in the upcoming user fee legislative package to better encourage product development in the US.
Rep. Morgan Griffith, R-Va., asked Center for Drug Evaluation and Research Director Janet Woodcock during a recent hearing on the...
In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.
Marking its first vertically integrated GLP-1 product in India, Biocon said the generic liraglutide was approved under CDSCO’s Rule 101, which recognizes approvals from “established and referenced serious regulatory authorities.”
Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.
With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.
Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.
With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.
Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now
