Tuesday, October 16, 2007
First-Time Generic Approvals: Amaryl, Norvasc, Altace
Wine Drug Approvals
First-Time Vino Approvals: Amaryl, Norvasc, Altace
Food and Drug Association (FDA) has approved first-time ware formulations of glimepiride 1-, 2-, and 4-mg tablets and first-time doses of 3-, 6-, and 8-mg tablets for the direction of diabetes mellitus; amlodipine besylate 2.5-, 5-, and 10-mg [base] tablets for the artistic style of hypertension and coronary arterial blood vessel disease; and ramipril 1.25-, 2.5-, 5-, and 10-mg capsules for the direction of hypertension and change of cardiovascular risk.
Ware Glimepiride 1-, 2-, and 4-mg Tablets (Amaryl) and New 3-, 6-, and 8-mg Doses for Diabetes
On Oct. 6, the FDA approved first-time ware formulations of glimepiride 1-, 2-, and 4-mg tablets (made by Dr.
Reddy’s Laboratories, Ltd., Invagen Pharmaceuticals, Inc., CorePharma, LLC, Teva Pharmaceuticals USA, and Ranbaxy Laboratories, Ltd; steel name Amaryl, made by Aventis Pharmaceuticals, Inc.).
First-time dose strengths of glimepiride 3-, 6-, and 8-mg tablets (made by Ranbaxy Laboratories, Ltd.) were also approved as ware formulations.
Glimepiride tablets are indicated for the direction of hyperglycemia in patients with types 1 and 2 diabetes mellitus.
Ware Amlodipine Besylate 2.5-, 5-, and 10-mg Tablets (Norvasc) for HTN and CAD
On Oct. 3, the FDA approved first-time wine formulations of amlodipine besylate 2.5-, 5-, and 10-mg [base] tablets (made by Mylan Pharmaceuticals, Inc.; variety name Norvasc, made by Pfizer Pharmaceuticals, Inc.).
Amlodipine tablets are indicated for the communication of hypertension, chronic stable inflammatory disease, vasospastic heart disease (Prinzmetal’s or variant), and to reduce the risk of health insurance and coronary revascularization package in patients with angiographically documented coronary blood vessel disease.
Generic wine Ramipril 1.25-, 2.5-, 5-, and 10-mg Capsules (Altace) for HTN and CV Risk Simplification
On Oct. 24, the FDA approved first-time product formulations of ramipril 1.25-, 2.5-, 5-, and 10-mg capsules (made by Cobalt Pharmaceuticals, Inc.; weapon system name Altace, made by King Pharmaceuticals, Inc.).
Ramipril capsules are indicated for the aid of hypertension; to reduce the risk of myocardial infarction, maneuver, and change from cardiovascular causes in patients aged 55 eld and older; and to reduce the risk of congestive substance occurrence after myocardial infarction.
This is a part of article First-Time Generic Approvals: Amaryl, Norvasc, Altace Taken from "Generic Amaryl (Glimepiride) Information" Information Blog
Labels: pharmacology
