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FDA okays the first short-acting insulin approved as a “follow-on” product.
FDA approved the first short-acting insulin approved as a “follow-on” product.
Insulin lispro injection (Admelog, Sanofi-Aventis) is indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus
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“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease,” said FDA Commissioner Scott Gottlieb, MD, in a statement from FDA. “In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.”
Admelog was approved through an abbreviated approval pathway, the 505(b)(2) pathway, under the Federal Food, Drug, and Cosmetic Act. A new drug application submitted through this pathway may rely on FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified.
In the case Ademelog, Sanofi-Aventis cited FDA’s findings of safety and effectiveness for Humalog.
“The use of abbreviated pathways can reduce drug development costs so products can be offered at a lower price to patients,” FDA said in the statement.
Admelog can be administered by injection under the skin, subcutaneous infusion (i.e., via insulin pump), or intravenous infusion. Dosing of Admelog should be individualized, based on the route of administration and the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal.
The most common adverse reactions associated with Admelog in clinical trials was hypoglycemia, itching, and rash. Other adverse reactions that can occur with Admelog include allergic reactions, injection-site reactions, and thickening or thinning of the fatty tissue at the injection site (lipodystrophy).
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