Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
The alarming statistics on prescription opioid overdoses are well known to medical professionals, thanks to the Centers for Disease Control and Prevention (CDC)’s widely cited finding that deaths from opioid analgesics have increased fourfold since 1999.1 Half of all fatal drug overdoses now involve opioids prescribed by a doctor. Meanwhile, a lack of rigorous research…
FDA Restricts Fluoroquinolone Use The U.S. Food and Drug Administration (FDA) has twice previously communicated safety information about systemic fluoroquinolones—in August 2013 and July 2008. The safety issues of this medication class described in its latest Drug Safety Communication were also discussed at a November 2015 FDA Advisory Committee meeting.1 The FDA is now advising…
In a global Phase 3 trial, subcutaneous secukinumab proved safe and effective in patients with psoriatic arthritis. Also, a version of aspartyl-alanyl diketopiperazine, a biologic for knee OA, has entered Phase 3 trials…
A recent study showed ustekinumab can be used to treat teens with moderate to severe psoriasis. Also, Phase 2 trials for an analgesic combination drug show it holds promise for reducing post-operative pain…
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.
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