Abstract:
OBJECTIVE:Generic drugs are identical or bioequivalent versions of the brand name drugs. They are the economic alternative of the costlier brand name drugs. This article presents a general overview of the procedure and regulatory aspects relating to generic drug approval in the US. METHODS:A computerized search was conducted to find literature on generic drug approval in the US. The literature was searched using the following key words: generic drug, brand name drug, Hatch-Waxman Act, Medicare Act, NDA, ANDA, CTD and exclusivity. FINDINGS:The search results were filtered for the literature describing and analyzing the procedure and regulatory provisions for generic drug approval in the US. After the screening total 19 applicable literature remained. CONCLUSION:In the US standardized procedures for the recognition of generic drugs have been laid down under the Drug Price Competition and Patent Term Restoration Act, 1984 (the Hatch-Waxman Act). Provisions of this Act such as patent challenge, patent term extension and data exclusivity have created profound effects on the approval, sale and distribution of the pharmaceuticals in the US. The Hatch-Waxman Act is an excellent piece of legislation that takes care of the rights of both the brand name and generic drug companies. This article presents only an overview of generic drug approvals and for all practical purposes official resources should be referred.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Nagori BP,Mathur V,Garg Sdoi
10.1185/03007995.2010.548374subject
Has Abstractpub_date
2011-03-01 00:00:00pages
541-5issue
3eissn
0300-7995issn
1473-4877journal_volume
27pub_type
杂志文章,评审abstract:OBJECTIVE:Parenteral sodium ferric gluconate in complex (Ferrlecit [branded SFG]) is used to treat patients with iron deficiency anemia undergoing chronic hemodialysis and receiving supplemental epoetin. This comparative pharmacokinetic study (GeneraMedix, Inc., Study 17909) evaluates whether the recently approved gene...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/03007995.2011.597738
更新日期:2011-08-01 00:00:00
abstract:OBJECTIVE:The best management of patients with femoropopliteal and infrapopliteal artery occlusion disease is not clear. This study aimed to compare the efficacy of drug-coated balloons (DCBs) and drug-eluting stents (DESs) with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal or infrapoplit...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析,评审
doi:10.1080/03007995.2017.1372114
更新日期:2018-01-01 00:00:00
abstract:UNLABELLED:The occurrence of intestinal bacterial overgrowth in patients with Crohn's Disease (CD) has been described and antimicrobial treatment has been shown to be effective in reversing this condition. However, the mechanisms underlying the efficacy of antimicrobial therapy are still only partially known. The aim o...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/0300799009117003
更新日期:2000-01-01 00:00:00
abstract::Forty patients with definite or classical rheumatoid arthritis were entered for 3 months in a double-blind trial, 20 patients each on 200 mg flurbiprofen or 4.0 g enteric-coated aspirin daily. Statistically significant improvements (Page Test, p less than 0.05) on flurbiprofen were reported during the course of the st...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998109114278
更新日期:1981-01-01 00:00:00
abstract:BACKGROUND:Improving health-related quality of life (HRQoL) should be a treatment goal for patients with Generalised Anxiety Disorder (GAD). OBJECTIVES:To assess the impact of treatment with escitalopram on HRQoL as well as the effect of relapse on HRQoL and work productivity. METHODS:This study was conducted alongsi...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/030079907X226087
更新日期:2007-10-01 00:00:00
abstract:OBJECTIVES:This survey explores how physicians perceive chronic non-cancer pain, and examines their opinions on current treatment options. METHODOLOGY:The computer-based survey comprises a questionnaire that is completed by physicians, mostly at professional conferences and congresses, but also online. The focus is on...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2012.674499
更新日期:2012-05-01 00:00:00
abstract:OBJECTIVES:To derive current real-world data on the rates and costs of severe hypoglycemia (SH) for people with type 2 diabetes mellitus (T2D) who have initiated basal insulin therapy and to examine differences in SH rates and costs stratified by history of prior SH events. METHODS:We used a nation-wide electronic hea...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2014.936930
更新日期:2014-10-01 00:00:00
abstract:OBJECTIVE:To evaluate the relative bioavailability of a new formulation containing 5 mg mosapride and 10 mg rabeprazole (T) and compare it with the branded formulations of both drugs co-administered in separate tablets (R) to meet the regulatory requirements of bioequivalence in Argentina. METHODS:A randomized-sequenc...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/03007995.2011.624088
更新日期:2011-11-01 00:00:00
abstract:BACKGROUND:The presence of midline shift on neuroradiologic studies in brain tumor patients represents mass effect from the tumor and surrounding edema. We hypothesized that baseline cerebral edema as measured by midline shift would increase postoperative nausea (PON). We studied the incidence of PON in brain tumor pat...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/03007995.2013.811071
更新日期:2013-09-01 00:00:00
abstract:OBJECTIVE:To test the hypothesis that first-line treatment with atomoxetine provides superior efficacy than placebo for up to 12 weeks in improving the symptoms of Attention Deficit/Hyperactivity Disorder (ADHD). RESEARCH DESIGN AND METHODS:This double-blind, randomized, placebo-controlled, parallel clinical trial inc...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007990903316152
更新日期:2009-11-01 00:00:00
abstract:OBJECTIVE:Evaluation of the safety and efficacy of insulin detemir (IDet) in the observational and non-interventional PREDICTIVE study. METHODS:A total of 2923 patients with type 1 or 2 diabetes on basal-bolus regimens were followed for 6 months: Group (1) NPH + human insulin (HI) bolus switching to IDet + analogue bo...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990903262885
更新日期:2009-11-01 00:00:00
abstract:BACKGROUND:Low-dose acetylsalicylic acid (ASA; aspirin; 75-325 mg/day) is effective for the prevention of cardiovascular events, and its use in this indication is rapidly increasing. However, the use of ASA and, indeed, other non-steroidal anti-inflammatory drugs (NSAIDs) is limited by the incidence of adverse gastrodu...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990903212682
更新日期:2009-11-01 00:00:00
abstract:PURPOSE:To determine whether a new category of artificial tear product, carboxymethylcellulose 0.5% with compatible solutes (CMC-solutes) (Optive, Allergan, Inc., Irvine, California) improves clinical outcomes when used adjunctively with topical cyclosporine 0.05% (Restasis, Allergan, Inc., Irvine, California) for the ...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/030079907X219670
更新日期:2007-09-01 00:00:00
abstract:OBJECTIVE:Short-term clinical trials have demonstrated the efficacy and safety of pregabalin in the treatment of generalized anxiety disorder (GAD). This study examined long-term safety and tolerability of pregabalin in patients with GAD, social anxiety disorder (SAD), or panic disorder (PD). RESEARCH DESIGN AND METHO...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1185/03007995.2013.820694
更新日期:2013-10-01 00:00:00
abstract::Insulin secretion was studied in 12 non-insulin dependent diabetics during middle-term administration of the sulphonylurea gliclazide. Blood sugar, C-peptide and glucagon were also estimated during the intravenous glucose tolerance and arginine tests performed before and after therapy. After 3 months of gliclazide the...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998409109560
更新日期:1984-01-01 00:00:00
abstract:OBJECTIVE:Neurogenic bladder refers to morphofunctional alterations of the bladder-sphincter complex secondary to central or peripheral neurological lesions. Discal etiology can be suggested by clinical observation in patients complaining of classical lower back pain, but not excluded even without musculoskeletal pain....
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2013.807788
更新日期:2013-08-01 00:00:00
abstract::Twenty-five acutely disturbed psychotic patients were treated in an open study with a single injection of zuclopenthixol acetate 5% in 'Viscoleo, a thin vegetable oil. Patients were assessed post-injection for 3 days using the BPRS, CGI, and a specially designed behaviour/activity scale. Doses of 50 to 150 mg proved e...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007999009111492
更新日期:1990-01-01 00:00:00
abstract:OBJECTIVE:Transient ischemic attack (TIA) is a serious condition which should be considered on the same spectrum as other conditions involving brain ischemia. Efficient management of these patients is therefore critical. The aim of this research was to gain insights into 'real-world' global trends of the current manage...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2011.652257
更新日期:2012-03-01 00:00:00
abstract:OBJECTIVE:The primary objective of the study was to compare the percentage of men with mean serum total T (C(ave(0-24))) within normal range during the 24-h pharmacokinetic (PK) sampling period on Days 14 and 15. METHODS:Treatment with a new testosterone (T) buccal system, (Striant), 30 mg twice daily was compared to ...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/030079904125003494
更新日期:2004-05-01 00:00:00
abstract::A total of 247 patients suffering from rheumatoid arthritis and allied conditions were referred for routine ophthalmological examination with particular reference to ocular rheumatoid involvement. Of these, 197 were already receiving ibuprofen before their first assessment while 50 had a baseline assessment before com...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997609109292
更新日期:1976-01-01 00:00:00
abstract:BACKGROUND:Tumor necrosis factor (TNF)-α plays a critical role in psoriasis pathogenesis, and several anti-TNF agents have been developed as therapeutic drugs in this indication. SCOPE:To present the preclinical rationale and clinical data for onercept, a novel anti-TNF agent developed for the treatment of moderate-to...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2010.507492
更新日期:2010-10-01 00:00:00
abstract:OBJECTIVE:In addition to direct weight reduction, there may be other benefits of obesity treatment including improved insulin sensitivity. The purpose of this study was to characterise concomitant diabetes drug use and the related costs in patients with diabetes treated with orlistat (Xenical) in the first 6 months of ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079905X74943
更新日期:2005-11-01 00:00:00
abstract:BACKGROUND:Although risk factors for MI have been described in the general population, there is a lack of data on the assessment of risk factors associated with MI in venous thromboembolism (VTE) patients. OBJECTIVE:The purpose of this study was to identify risk factors associated with MI in VTE patients. PATIENTS AN...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2013.852525
更新日期:2014-01-01 00:00:00
abstract:OBJECTIVE:To provide a commentary on recent studies with the new IOP-lowering fixed-combination product brinzolamide 1%/timolol 0.5%. METHODS:Medline was searched for brinzolamide/timolol fixed-combination clinical literature (up to May 18, 2010) and the current comprehensive brinzolamide/timolol literature was review...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2010.517718
更新日期:2010-11-01 00:00:00
abstract:BACKGROUND:Tobacco smoking is a major risk factor for cardiovascular disease, respiratory disease and cancer and, for current smokers, smoking cessation is one of the most effective therapeutic interventions for reducing the risk of all-cause morbidity and mortality. However, smoking cessation causes nicotine withdrawa...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990802707600
更新日期:2009-02-01 00:00:00
abstract:BACKGROUND:While arterial wall imaging has been used to characterize progression of atherosclerosis, there remain limitations to this approach. SCOPE:A selective overview of emerging modalities to image the artery wall and highlight how they may be used to evaluate emerging anti-atherosclerotic agents. FINDINGS:Ongoi...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990903547582
更新日期:2010-03-01 00:00:00
abstract:BACKGROUND:Studies have shown that many patients with type 2 diabetes do not achieve optimal glycemic control, and progression of diabetes over time requires more than one pharmacotherapy to achieve glycemic goal. OBJECTIVE:To examine the efficacy and safety of the fixed-dose combination (FDC) of pioglitazone 15 mg an...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007990903350011
更新日期:2009-12-01 00:00:00
abstract:BACKGROUND:Natalizumab is a highly effective treatment for patients with relapsing-remitting multiple sclerosis (RRMS). Treatment with natalizumab has been associated with progressive multifocal leukoencephalopathy (PML), a rare yet serious disease of the brain. Published studies have quantified the PML risk by the pre...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2013.869492
更新日期:2014-04-01 00:00:00
abstract:OBJECTIVE:To determine the efficacy and safety of lumiracoxib for knee osteoarthritis (OA). METHODS:This was a 13-week, multicentre, randomized, double-blind, double-dummy, placebo-controlled study. Males or females aged >/= 18 years with primary knee OA received lumiracoxib 100 mg od, lumiracoxib 100 mg od with a loa...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/030079905x38196
更新日期:2005-04-01 00:00:00
abstract:MOTIVATION:The American Society of Parenteral and Enteral Nutrition (ASPEN) guidelines advise use of enteral nutrition (EN) for critically ill hospital patients requiring nutritional support, but no studies have comprehensively estimated economic benefits from adherence to this recommendation. METHODS:We systematicall...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析,评审
doi:10.1185/03007995.2010.545816
更新日期:2011-02-01 00:00:00