Repaglinide Receives Abbreviated New Drug Application

Repaglinide Receives Abbreviated New Drug Application

RepaglinideOn January 24, 2014 the U.S. Food & Drug Administration {FDA} announced their approval for an abbreviated new drug application for anti-diabetic Repaglinide tablets. The generic formulation of the Prandin tablets, in both one and two milligram strengths will be produced by Perrigo. The advent of the abbreviated new drug application for Repaglinide is sure to be a boon for sales, as the Prandin brand already garnishes $250 million dollars in sales annually. As with virtually all of the type 2 diabetes medications, Repaglinide is best when taken in conjunction with a healthy diet which promotes optimal glycemic control and regular exercise.

Clinical trials of Repaglinide have been viable and successful. One such promising study was a placebo controlled and double-blind study lasting approximately four weeks. This study involved 138 people who were diagnosed with type 2 diabetes mellitus. The participants were given Repaglinide in various dosages, ranging from 0.25 milligrams to 4 milligrams, three times daily. The patients were dosed with Repaglinide adjunctively with meals, and they all demonstrated minimal adverse effects. Results from this study were overwhelmingly positive, showing dose-proportional lowering of the glucose levels in patients throughout the entire range of participant doses. Additionally, patients showed considerable improvements in their fasting blood glucose rates in as little as between one and two weeks’ time.

Type 2 diabetes is a serious disease that is a great concern worldwide due to the rising number of patients diagnosed with type 2 daily. Physicians are beginning to take note of the relationship of fasting glucose levels {A1C} and the likelihood of a future diagnosis of type 2 diabetes in patients. Recently released statistics show that roughly 35 percent of adults in America age 20 and older are considered pre-diabetic based on their A1C levels. American adults ages 65 and older have a 50 percent rate of pre-diabetes. These staggering numbers are only certain to grow.

LGM Pharma provides Repaglinide CAS# 135062-02-1, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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