Approvals
For fiscal year 2019, the agency reported 1,171 generic drug approvals, 935 of them full approvals and 236 tentative approvals. This is up from last year’s all-time record of 971 generic drug approvals.
The patch is a once-per-day treatment that provides sustained concentrations of Secuado (asenapine), an atypical antipsychotic drug used to treat schizophrenia.
The U.S. Food and Drug Administration approved Janssen Pharmaceutical’s Xarelto for the prevention of venous thromboembolism, or blood clots, in acutely sick patients in hospitals who are at risk for blood clots but who are not at high risk of bleeding.
The U.S. Food and Drug Administration approved Eli Lilly’s Reyvow (lasmiditan) for the acute treatment of migraines.
Scenesse is an under-the-skin implant. The drug is the company’s only approved product.
The approval of Beovu was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Novartis’ drug demonstrated non-inferiority versus Eylea in mean change in best-corrected visual acuity at 48 weeks.
The approval was based on data from the Phase III GRECO clinical trial and the Phase I AMES trial.
The only other drug currently approved in the U.S. for HIV PrEP is Gilead’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
Janssen’s Invokana snagged another regulatory approval to reduce the risk of end-stage kidney disease, cardiovascular death and worsening of kidney function in adults with type 2 diabetes and diabetic kidney disease.
The FDA’s latest approval for Darzalex is based on results from the Phase III CASSIOPEIA trial that showed the addition of Darzalex to VTd before and after ASCT resulted in deeper responses in patients with the blood cancer.
PRESS RELEASES