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Insulin Glargine News
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...
ADA: Glycemic Control Up With Weekly Icodec Versus Daily Insulin Glargine
MONDAY, June 26, 2023 – For adults with type 2 diabetes, glycemic control is significantly better with once-weekly icodec than once-daily insulin glargine U100, according to a study published online...
FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery
May 19, 2023 – Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes....
FDA Medwatch Alert: Mylan Pharmaceuticals Inc. Issues Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens U-100, Due to the Potential of Missing Labels on Some Pens
PITTSBURGH – July 5, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL pre...
FDA Medwatch Alert: Mylan Issues Voluntary Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label
April 12, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine- yfgn) Injection, 100 units/mL (U-100), which is packaged i...
FDA Medwatch Alert: Mylan Conducting Voluntary Recall of One Batch of Semglee (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens Due to the Potential for a Missing Label
PITTSBURGH – Jan. 18, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3...
FDA Approves Semglee (insulin glargine-yfgn) as the First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
SILVER SPRING, Md., July 28, 2021 /PRNewswire/ – Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in a...
FDA Approves Semglee (insulin glargine injection) for Type 1 and Type 2 Diabetes
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 11, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food an...
FDA Medwatch Alert: Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication
Audience: Patients and caregivers who use or are considering using pen injectors with pen needles to inject prescription medicines. Health care providers who treat patients, or who train...
FDA Approves Toujeo (insulin glargine) Max SoloStar
BRIDGEWATER, N.J., March 27, 2018 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) approved Sanofi's Toujeo (insulin glargine 300 Units/mL) Max SoloStar, the highest capacity long-acting...
Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes
PARIS, Nov. 21, 2016 /PRNewswire-USNewswire/ – Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection)...
FDA Approves Basaglar (insulin glargine) for Type 1 and Type 2 Diabetes
December 16, 2015 – The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric...
Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo
PARIS, Feb. 25, 2015 – Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal...
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Diabetes, Type 2, Diabetes, Type 1