FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar to its reference product Novolog (insulin aspart), to improve glycemic control in adults and children with diabetes mellitus.
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CDER Small Business and Industry Assistance (SBIA) helps small pharmaceutical business and industry navigate the wealth of information that FDA offers, and provides assistance in understanding the regulation of human drug products.Information for Consumers and Patients | Drugs
Drug Information for Patients and ConsumersList of Determinations Including Written Request
In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
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