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 ...

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 ...

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 ...

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 ...

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 ...

The Food and Drug Administration has relaxed label requirements for taking the abortion-inducing mediation Mifeprex (mifepristone), a move that may make it easier to prescribe the drug in states that ...

The Food and Drug Administration (FDA) provides a barrier to market entry and use of unproven and unsafe products. For prescription drugs, the FDA approval process requires substantial evidence of ...

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 FDA's approval of Intuniv brings to four the number of drugs for ADHD currently marketed by Shire. (The other three are Adderall XR, Vyvanse and the Daytrana patch.) There are about 11 drugs on ...