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Generic Drug Sponsors Seek Advance Notice Of Approvals From US FDA

 
• By Sue Sutter

Pre-launch communication from agency would allow sponsors to ramp up commercial activities and could head off some innovator company legal challenges to ANDA approvals, attorneys say; CDER’s Moscicki suggests GDUFA goal dates now provide sponsors some level of predictability.

Launch Plans words stamped in red ink on yellow envelope offering advice, information

Generic drug sponsors are seeking the US FDA’s assistance to help them better prepare for product launch immediately upon abbreviated new drug application (ANDA) approval.

At the Food and Drug Law Institute’s recent annual meeting, Rachel Turow, executive counsel for regulatory law at Teva...

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ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By Dean Rudge

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
• By Dean Rudge

Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.

More from Biosimilars & Generics

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.