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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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MAHA, Nutrition, and the FDA

The FDA Law Blog

More recently, the agency invested significant efforts in modernizing nutrition labeling requirements and implementing a sodium reduction initiative. However, it’s fair to say that FDA’s food program has focused primarily on implementation of the many mandates in the Food Safety Modernization Act of 2011.

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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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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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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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Can you take losartan and amlodipine together?

The Checkup by Singlecare

Additionally, the FDA hasn’t listed any known interactions for the medications on the losartan or amlodipine labels. A 2011 study showed that the combination is more effective than amlodipine monotherapy, while one from 2023 demonstrated that it’s more effective than taking losartan alone.

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

The FDA Law Blog

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Kirschenbaum — The Inflation Reduction Act (IRA) significantly changed the Part D benefit.

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