FDA added new safety labeling changes for a class of antibiotics, fluoroquinolones (Levaquin, Cipro and other branded drugs), to enhance warnings about their association with disabling and potentially permanent side effects. Plus, the new labeling says that the drugs’ use should be limited in patients with less serious bacterial infections.
FDA approved lixisenatide (Adlyxin, Sanofi-Aventis), a once-daily mealtime GLP-1 receptor agonist injection for type 2 diabetes, which will compete against the once-weekly pen dulaglutide (Trulicity, Eli Lilly) and the injectable liraglutide (Victoza, Novo Nordisk).
FDA recently approved the New Drug Application (NDA) for (lorcaserin HCl) CIV extended-release 20 mg tablets (Belviq XR, Eisai Inc. and Arena Pharmaceuticals), a once-a day dosing option for chronic weight management.
FDA approved evolocumab (Repatha, Amgen) Pushtronex system, the first monthly single-dose injection of a PCSK9 inhibitor. Repatha was already approved by FDA as the only PCSK9 inhibitor with a monthly dose last August.
Expanding access to buprenorphine, a medication to treat opioid use disorder, is one of several new actions announced by Health and Human Services (HHS) to combat the opioid epidemic. Here are the top 4 new provisions from HHS.
For the first time, FDA approved dronabinol oral solution (Syndros, Insys Therapeutics), a liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC").
The results of a study indicated that only 36% of COPD patients were prescribed treatment according to the GOLD guidelines. The patients that were on GOLD-recommended pharmacological therapy had a moderate improvement in symptoms and health resource utilization.