Insulin | FDA - U.S. Food and Drug Administration
My Insulin. Ask your healthcare provider these questions before you start using your insulin. How will my insulin affect my blood sugar? Will it affect my other medicines? What are the side...
FDA Approves First Interchangeable Biosimilar Insulin Product …
Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type...
FDA Approves Insulin Product - U.S. Food and Drug Administration
Jun 11, 2020 · Today, the U.S. Food and Drug Administration approved a new insulin product, indicated to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with...
Newsom committed California to making its own insulin. It’s at …
Jan 15, 2025 · Gov. Gavin Newsom’s ambitious plan to produce a cheap, generic insulin for the 3.2 million Californians with diabetes is behind the schedule he announced and unlikely to make it to market for several years, industry experts say.
FDA advisers weigh benefits of weekly insulin for people with ... - CNN
May 24, 2024 · In a meeting Friday, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee weighed whether the benefits of Novo Nordisk’s weekly product, called insulin icodec, outweigh its risks....
FDA Clears First Automated Device to Deliver Insulin to ... - Drugs.com
TUESDAY, Aug. 27, 2024 -- The U.S. Food and Drug Administration on Monday approved the expanded use of an automated insulin pump system to include those with type 2 diabetes. It's the first such system for use by people with the more prevalent type 2 form of the disease.
FDA allows automatic ‘generic’ swap for brand-name insulin
Jul 29, 2021 · U.S. regulators took action Wednesday that will make it easier to get a cheaper, near-copy of a brand-name insulin at the drugstore. Doctors now have to specifically prescribe what’s called a...
Insulins as Drugs or Biologics in the USA: What Difference Does it …
The insulins are well-established products that have been regulated by the US Food and Drug Administration (FDA) for many decades; however, their regulatory status will change on 23 March 2020 as a matter of law, even though the products themselves will stay the same.
FDA finalizes rule to regulate insulin as biological product
Feb 20, 2020 · The Food and Drug Administration today released a final rule regulating certain protein products, such as insulin, as biological products rather than drugs effective March 23.
Afrezza (Insulin Human) Inhalation Powder Approved for the …
On June 27, 2014, the US Food and Drug Administration (FDA) approved insulin human inhalation powder (Afrezza; MannKind Corporation), a rapid-acting inhaled insulin that is used to improve glycemic control in adults with diabetes. 8.