FDA-Issued Kratom Recall Highlights AJPB Week in Review

5. FDA Issues Refusal to File Letter for Major Depressive Disorder Drug

The FDA issued a Refusal to File letter regarding its new drug application for ALKS 5461 for adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies. Read more.

4. Antibiotics May Increase Heart Disease Risk in Older Women

Women who take antibiotics for long periods, especially in late adulthood, have an increased risk of death from heart disease and in general. Read more.

3. FDA Expands Bydureon Indication in Type 2 Diabetes

The FDA approved an expanded indication for exenatide extended-release (Bydureon) for its use as an add-on therapy to basal insulin in adults with type 2 diabetes with inadequate glycemic control, announced AstraZeneca. Read more.

2. Drug Combo Improves Activity in Heart Failure Patients

Treatment with sacubitril/valsartan (Entresto) improved several types of physical and social activities in heart failure patients with reduced ejection fraction compared with enalapril. Read more.

1. FDA Issues Kratom Recall Over Salmonella

In a first-time issuance under the Food Safety Modernization Act, the FDA has announced a mandatory recall order for all food products containing powdered kratom that were manufactured, processed, packed, or held by Triangle Pharmanaturals LLC. Read more.