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Skinny Label and Induced Infringement: The Saga Continues

The FDA Law Blog

government in the now-infamous (at least in FDA circles) Teva v. GSK skinny label case , the U.S. The Government’s concern goes far beyond this case: Like many generic drug sponsors, the Government raises concerns of the implications of the outcome of this case on the skinny label pathway itself.

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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.

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

pharmaphorum

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The post FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis appeared first on.

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Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod

pharmaphorum

The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product. The post Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod appeared first on.

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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. . The post Apellis set to take on Alexion as FDA clears PNH drug Empaveli appeared first on.

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Vyvanse generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2007 for treatment and symptom control in ADHD. In 2015, Vyvanse was approved by the FDA also to treat binge eating disorder ( BED ). Generally speaking, the FDA approval process ensures no significant difference between brand and generic drugs.

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New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

The FDA Law Blog

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub.