INTRODUCTION New Zealand's Pharmaceutical Management Agency (PHARMAC) manages the list of medicines available for prescribing with government subsidy, within a fixed annual medicines budget. PHARMAC achieves this through a mix of pricing strategies including reference pricing. In 2011, PHARMAC applied generic reference pricing to olanzapine tablets. AIM This study sought to evaluate change in...

In view of an increasing number of generic drugs emerging, a comparative study was performed including the approved lisinopril preparations in the form of tablets marketed in Croatia, to compare purity profiles of generic drugs versus the original medicinal product. Several batches of each individual medicinal product at different stages of their shelf life were analyzed. Impurities were determ...

NEW DRUGS Generic Desogestrel/Ethinyl Estradiol Contraceptives Watson Pharmaceuticals, Inc., has announced the final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for desogestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg, a generic version of OrthoMcNeil’s Ortho-Cept® and Organon’s Desogen®. These products are indicated for th...

Amlodipine is a dihydropyridine drug that used to lower high blood pressure. In this study, the photostabilities of orally disintegrating (OD) amlodipine tablets, both original and generic versions, their powdered suspended forms were evaluated. The concentration active pharmaceutical ingredient (API) was monitored by high-performance liquid chromatography (HPLC), revealing residual amounts API...

BACKGROUND Montelukast is a leukotriene receptor antagonist. The release of leukotrienes causes narrowing and constricting in the respiratory airways. Blocking the action of these leukotrienes, montelukast can be used for the prophylaxis and treatment of chronic asthma. OBJECTIVE The aim of this study was to evaluate the interchangeability and comparative effectiveness between a generic and a...

      In this study, the pharmacokinetic parameters of two marketed tablet formulations of ketoconazole were studied, and the relative bioavailability of the test formulation was compared with a reference formulation. A single dose (12x2) double blind randomized cross-over study of a generic formulation of ketoconazole tablet (2x200 mg), and a commercial brand, Nizoral tablet (2x200 mg, Janssen...

A procedure to evaluate the quality consistency of generic drugs based on the impurity profile and the similarity analysis methods was presented in this paper. Nifedipine extended-release tablets from six generic factories of China were used to evaluate the uniformity with the original drug in the study. The procedure includes: choice of chromatographic methods, data collection and conformity t...