article thumbnail

Skinny Label and Induced Infringement: The Saga Continues

The FDA Law Blog

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

article thumbnail

Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug

pharmaphorum

The case hinges around the concept of “ skinny labelling ” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-called “use” patents. The substance patent expired in 2007.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

FDA-Approved Labeling: Is Enough Enough?

The FDA Law Blog

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

article thumbnail

FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

pharmaphorum

The approval comes a few weeks after the biosimilar was cleared for marketing in the EU with a broader label, as it also includes diabetic macular oedema (DMO), another of Lucentis’ approved indications. Sales reached a peak in 2019, when Roche booked $1.8 billion in sales from the drug while Novartis made $2.1 billion and $1.9

FDA 72
article thumbnail

Vyvanse generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2007 for treatment and symptom control in ADHD. The manufacturer lists cocaine dependence as an off-label use. All amphetamine-derived ADHD medications belong to this schedule of drugs. Non-amphetamine-based ADHD treatments, such as Strattera , are not controlled substances.

Dosage 92
article thumbnail

Apellis set to take on Alexion as FDA clears PNH drug Empaveli

pharmaphorum

Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly. . billion and $1.1 billion respectively last year, although Soliris could lose patent protection next year.

FDA 52
article thumbnail

Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod

pharmaphorum

Byooviz launched on 1 July at a 40% discount to Lucentis, with a label that covers use of the biosimilar for wet age-related macular degeneration (AMD), macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularisation. Roche has US marketing rights to the drug, and booked $1.3

FDA 59