Tag Archives: OffLabel

First, a pricing scandal for Catalyst’s Firdapse. Next, off-label competition?

For decades, Jacobus Pharmaceuticals gave away the unapproved drug amifampridine to patients with a rare neuromuscular disorder called LEMS. Then, Catalyst Pharma licensed certain rights to the drug, scored an FDA nod, and priced the med at $ 375,000 a year. An outcry ensued. But now, the FDA may have given patients a workaround. Jacobus… Read More »

On Relaxing Off-Label Meds: Do the Opposite. Especially for Children

On Relaxing Off-Label Meds: Do the Opposite. Especially for Children … The US Food and Drug Administration has announced that there will soon be a public meeting to explore providing drug companies with greater flexibility in promoting off-label indications to doctors. When it comes to prescribing medications to children … Read more on Mad In… Read More »