The Skinny Labels, Big Savings Act was introduced on January 9 in an effort to provide “a statutory safe harbor from patent ...

Aggressive policies that target the use and promotion of off-label use are needed to prevent the use of drugs for non-approved indications with little benefit or with harmful outcomes. It should be ...

American company Eli Lilly said it does not endorse the off-label use of Mounjaro (tirzepatide) for cosmetic weight loss. “Patient safety is Lilly’s top priority, and Lilly ne ...

In a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration. This ...

The Food and Drug Administration (FDA) has approved new labeling for Naftin (naftifine HCl cream 2%; Merz Pharmaceuticals) adding additional information regarding use in the pediatric population. The ...

Doctors often prescribe antidepressants to tackle conditions like migraine headaches for which they aren’t technically approved. Now, researchers say such “off-label” usage mostly occurs without clear ...

The majority of patients prescribed antipsychotic medications in state Medicaid programs are taking these agents for off-label indications. Continuously enrolled patients with at least 1 prescription ...

Laura Johnson, senior director, sales, life sciences, Loftware, discusses ways that digital passports can help ensure patients receive the correct medication. Drug labeling has become a key issue in ...

Off-label prescribing is when a medication is prescribed for a purpose not approved by the FDA. Insurance might cover off-label prescriptions, but it depends on the specific plan and often requires a ...

Dabigatran has been readily integrated into clinical practice in the United States, primarily for treatment of atrial fibrillation (A-fib) but increasingly for off-label indications as well, according ...

The Food and Drug Administration (FDA) authorizes the marketing of drugs only for uses that the manufacturer has demonstrated to be safe and effective. However, the FDA does not regulate medical ...