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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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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.

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Red 40 side effects and how to avoid them

The Checkup by Singlecare

Red Dye 40 is among the most commonly used artificial food dyes in the United States, and you might see it labeled under a different name on the products you consume. Regardless of what manufacturers label it as, there have been ties to specific negative side effects when ingested too frequently. 40 Aluminum Lake, and FD&C Red No.

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Is Adderall a controlled substance?

The Checkup by Singlecare

Food and Drug Administration (FDA) to treat symptoms of ADHD, as well as narcolepsy. Ideally, that place will be dry and at room temperature, which means 68° to 77°F, according to the FDA label. In 2007, the DEA changed regulations to allow up to 90 days of a schedule II controlled substance to be written at a time.

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Interview: Dr Alan S Louie – US Food and Drug Administration Delays

Pharmaceutical Technology

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? In terms of concerns over safety, it has meant that the FDA has been essentially very cautious in moving forward.