Reformulated opioid still doesn’t have abuse deterrence claim; Shire gains another indication for Vyvanse, this time in binge-eating; Imbruvica becomes the first drug approved for Waldenstrom’s macroglobulinemia; and, Alcon garners approval for once-daily eye drop.
Zogenix Inc.’s new formulation of Zohydro ER cleared FDA Jan. 30, but a decision on whether the extended-release hydrocodone product is deserving of abuse-deterrent labeling language will await further studies.
The new formulation incorporates BeadTek technology, which creates a viscous gel if the product is crushed and dissolved in liquid, Zogenix said
The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.
The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.
The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.
A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.
