Over 80% of U.S. drug prescriptions are for generic medicines. 1 Such medicines are an important part of the medical system, helping to alleviate drug shortages and improve access to affordable ...

The US Food and Drug Administration (FDA) has published a new draft guidance on the studies needed to support an abbreviated new drug application (ANDA), more commonly known as generic drug ...

The International Council for Harmonisation (ICH) recently adopted its M13A guideline, which aims to harmonize the framework for assessing the bioequivalence (BE) of immediate-release (IR) solid oral ...

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed ...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition ...

Objective: To evaluate the bioequivalence of two enteric-coated formulations of omeprazole, Losec ® (reference) and Omepradex ® (test). It is hypothesised that formulation differences may be ...

Generic atorvastatin offers a cost-friendly alternative to brand-name Lipitor, with studies showing comparable cholesterol-lowering effects when quality standards are met. Regulatory agencies like the ...

The FDA’s finding that the Impax/Teva generic Wellbutrin XL 300 is not the bioequivalent of the GSK product has narrowed the generic antidepressant market to four distributors. The FDA’s findings ...

There are over 250 functional drugs manufacturing companies that need to sell the products they are making. Now, how are they selling these drugs? Medical representatives or promotional officers of ...

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Samchundang Pharm surged to the upper price limit early in trading on July 23. This sharp rise is attributed to strong buying interest following the news that the company had successfully completed a ...

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