Vanda’s Fourth Suit Against US FDA Claims Agency Shared Its Manufacturing Trade Secrets
Executive Summary
Vanda is fighting FDA’s rejection of jet lag indication for Hetlioz as it faces generic competition for sleep-wake disorder treatment. Federal Circuit finds four Hetlioz patents invalid.
You may also be interested in...
Senate Committee Passes Moderate PBM Reform, But Has Its Eyes On Stronger Policies
Delinking pharmacy benefits managers’ compensation from the prices of drugs received bipartisan rhetorical support at a HELP markup, but the panel only cleared less drastic PBM reforms along with generic and orphan-drug focused policies. Approved amendments tackled step therapy, pharma transparency and PBM gag clauses, among other topics.
Absence Of Braille In Generic Hetlioz Label Merits Its Withdrawal, Vanda Lawsuit Argues
Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.
US Federal Circuit Pauses Teva, Apotex After Hetlioz Patent Win
Teva and Apotex must put their plans to launch generic versions of Vanda’s Hetlioz on ice after the originator was granted – for now – a small injunction against the ANDA sponsors.