FDA Approval Activities for this Drug…

Starlix (nateglinide) Tablets, Novartis NDA 21-204/S6 1020/03 10/27/03 10/27/03 Starlix (nateglinide) Tablets, 60 mg and 120 mg., Novartis NDA 21-204/S5 11/26/02 12/9/02 12/4/02 Starlix (nateglinide) Tablets, 60 mg and 120 mg. Novartis NDA 21-204 12/22/00 1/9/01 1/9/01 3/18/02 Starlix Indication: Provides for the use of Starlix as monotherapy, as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. In addition, it provides for the use of Starlix concomitantly with metformin to improve glycemic control. Risperdal Consta (risperidone) Long -Acting Injection, Johnson & Johnson Starlix (nateglinide) Tablets, Novartis Pharmaceuticals, Labeling Revision

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