Generics Bulletin is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Generics

Set Alert for Generics

AAM Urges US Senate To Back Domestic Production

While the AAM is lobbying for a renewed focus on domestic drug production amid fresh concerns about the globalization of the US pharmaceutical drug supply chain, the association has urged US Congress to have confidence in FDA oversight, insisting that “the US has one of the safest drug supply chains in the world.”

Manufacturing United States

FDA Re-Evaluates Orange Book Patents

With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.

Intellectual Property Regulation

Alvogen Group Unveils Adalvo B2B Unit

The Alvogen group of companies has unveiled Adalvo as the new identity for its B2B business unit. In an exclusive interview, general manager Anil Okay talks to Generics Bulletin about the reasons behind the rebranding, what makes it unique in the B2B sphere, and the significance of 2023 for Adalvo’s strategy.

Strategy Manufacturing

CJEU Opinion Backs Lundbeck Fine Over Citalopram ‘Pay For Delay’ Deals

A CJEU advocate general has backed a European Commission fine of almost €94m imposed on Lundbeck over “pay for delay” deals struck with four generics firms over citalopram.

Legal Issues Regulation

Meitheal Introduces US Enoxaparin

Meitheal has launched enoxaparin in the US following its FDA approval towards the end of last year.

Launches United States

FDA Asks For Input On Therapeutic Equivalence

The FDA wants to know if the second letter in its product equivalence ratings system is helpful and whether changes could make the information more user-friendly.

Regulation United States
See All
UsernamePublicRestriction

Register