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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.”

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FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-Contact

The FDA Law Blog

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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BMS Receives the US FDA’s Approval of Camzyos (mavacamten) sNDA for Label Update to Treat Symptomatic Obstructive HCM

PharmaShots

Shots: The US FDA approved an updated label for mavacamten (2.5/5/10/15mg Shots: The US FDA approved an updated label for mavacamten (2.5/5/10/15mg

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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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What states use Ozempic the most?

The Checkup by Singlecare

Most healthcare providers will prescribe Ozempic off-label or Wegovy only if weight loss can reduce the risk of a more serious health condition. More than 50% of study participants taking Wegovy reported a 15% reduction in their overall weight and more than 75% of them lost at least 10% of their body weight.

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GSK’s Benlysta claims first FDA okay for lupus kidney damage

pharmaphorum

The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the drug beyond its earlier label covering the treatment of active systemic lupus erythematosus (SLE) in combination with other medicines.

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Lipitor generic availability, cost, and dosage

The Checkup by Singlecare

Generic availability | Lipitor vs. atorvastatin | Cost | Off-label use | How to switch Would it surprise you to know that almost 25 million adults in the U.S. The generic version of Lipitor became available in 2011 and is one of the most prescribed drugs in the United States today. market and has been prescribed to millions of people.

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