Elite's Opioid Carries Risk Of Overdose After Heavy Meal, FDA Says
Complete response letter explains that SequestOx labeling could not adequately mitigate the risk; firm to propose another bioequivalence study in patients receiving drug after eating fatty food.
You may also be interested in...
Keeping Track: Approval Elusive For Biosimilar Neulasta; Valeant Gets A Nod And A No From FDA; Submissions From Amgen, Puma, Bristol
The latest drug development news and highlights from our FDA Performance Tracker
Can KemPharm's Apadaz Meet FDA Opioid Abuse Deterrent Standards?
Company cites FDA 'confusion' and indicates it will drop the product without the claim.
Keeping Track: Approvals For Nuplazid, Cabometyx, Bevespi And More; Digital Aripiprazole Tablet Needs More Study
The latest drug development news and highlights from our FDA Performance Tracker.