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Nov. 11, 2007 — The U.S.
Food and Drug Judicature (FDA) has approved first-time product
formulations of glimepiride 1-, 2-, and 4-mg tablets and first-time
doses of 3-, 6-, and 8-mg tablets for the establishment of diabetes
mellitus; amlodipine besylate 2.5-, 5-, and 10-mg [base] tablets for
the aid of hypertension and coronary arterial blood vessel disease; and
ramipril 1.25-, 2.5-, 5-, and 10-mg capsules for the care of
hypertension and decrease of cardiovascular risk.

On
Oct. 6, the FDA approved first-time product 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; name 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 wine formulations.

Glimepiride tablets are indicated for the governing body of hyperglycemia in patients with types 1 and 2 diabetes mellitus.

On
Oct. 3, the FDA approved first-time ware formulations of amlodipine
besylate 2.5-, 5-, and 10-mg [base] tablets (made by Mylan
Pharmaceuticals, Inc.; arm name Norvasc, made by Pfizer
Pharmaceuticals, Inc.).

Amlodipine tablets are indicated for
the care of hypertension, chronic stable angina pectoris, vasospastic
heart disease (Prinzmetal’s or variant), and to reduce the risk of
health insurance and coronary revascularization software package in
patients with angiographically documented coronary blood vessel disease.
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.; blade name Altace, made by King Pharmaceuticals, Inc.).

Ramipril
capsules are indicated for the artistic style of hypertension; to
reduce the risk of myocardial infarction, solidus, and killing from
cardiovascular causes in patients aged 55 eld and older; and to reduce
the risk of congestive warmness nonstarter 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

# posted by Haig Aglaia @ 2:39 AM