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Regulatory Divergence in Narrow Therapeutic Index Drugs: A Comparative Review of the US, EU, Japan, Canada, and South Korea.

Generic drugs offer cost-effective alternatives to brand-name medications while ensuring comparable safety and efficacy. However, narrow therapeutic index drugs (NTIDs), which require precise dosing due to narrow margins between therapeutic and toxic concentrations, present additional regulatory challenges. Concerns regarding the interchangeability of generic NTIDs are amplified by international variation in definitions, bioequivalence (BE) standards, and regulatory approaches. This systematic review compares NTID-related regulatory frameworks across major authorities to inform the development

A year in review: new treatments and expanded indications in dermatology in 2024.

METHODS: A literature search was conducted on Drugs@FDA: FDA-Approved Drugs for the year 2024 to identify new dermatologic treatments. RESULTS: In 2024, the FDA approved seven new dermatologic therapies and expanded the indications for seven current therapies. These therapies treat conditions such as atopic dermatitis, hidradenitis suppurativa, prurigo nodularis, molluscum contagiosum, and alopecia areata, among others. Some of these advancements converge dermatology with rheumatology, gastroenterology, and oncology, which continue to transform therapy for patients with multiple diseases. CO

The position of strontium ranelate in today's management of osteoporosis.

Osteoporosis accounts for about 3 % of total European health-care spending. The low proportion of costs for the pharmacological prevention of osteoporotic fracture means that it is highly cost saving, especially in patient with severe osteoporosis or patients who cannot take certain osteoporosis medications due to issues of contraindications or tolerability. Following recent regulatory changes, strontium ranelate is now indicated in patients with severe osteoporosis for whom treatment with other osteoporosis treatments is not possible, and without contraindications including uncontrolled hyper

New pharmacological treatments for the management of obesity.

Obesity is quickly becoming the leading preventable cause of death in the USA. Over 60 obesity-related comorbidities exist which increase the complexity and cost of medical care in obese patients. Even a moderate weight loss of 5 % can reduce morbidity associated with these conditions. Lifestyle modification through caloric restriction and enhanced exercise and physical activity remain the first line treatment for obesity. The development of pharmacologic agents for the treatment of obesity has been challenged by both lack of efficacy and serious adverse side effects leading to their removal f

Intussusception among recipients of rotavirus vaccine: reports to the vaccine adverse event reporting system.

BACKGROUND: Rotavirus vaccine was licensed on August 31, 1998, and subsequently recommended for routine use among infants. To assess rare adverse events, postlicensure surveillance was conducted. OBJECTIVE: To describe the cases of intussusception among rotavirus vaccine recipients reported to the Vaccine Adverse Event Reporting System from October 1998 through December 1999. SETTING AND PARTICIPANTS: Infants vaccinated with rotavirus vaccine in the United States. OUTCOME MEASURES: Intussusception confirmed by radiology, surgery, or autopsy report with medical record documentation or confir

Indication Expansion Dynamics and Trial Characteristics of Novel Multi-Indication Anti-Cancer Drugs in China (2000-2024): A Cross-Sectional Study.

PurposeTo perform a cross-sectional analysis of the indication expansion trends and pivotal trial features of novel multi-indication anti-cancer drugs approved in China from 2000 to 2024.MethodsWe conducted a cross‑sectional review of 74 novel multi-indication anti-cancer drugs approved by the National Medical Products Administration (NMPA) in China from 2000 to 2024, encompassing 265 total indications. Data were collected from multiple sources, including the NMPA, the Center for Drug Evaluation (CDE) of the NMPA, the National Healthcare Security Administration (NHSA), ClinicalTrials.gov, and

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… This indicates a lag in the alignment of healthcare insurance coverage with drug approvals. … Trends and characteristics of new drug approvals in China, 2011-2021. Ther Innov Regul Sci . 2023;57(2):343–351. doi: 10.1007/s43441-022-00472-3 31. Qiu H, Cao S, Xu R. …

International approval of Chinese pharmaceuticals: a USA-anchored analysis with comparative insights from Europe and other markets.

BACKGROUND: China-developed drugs (CDDs) have become increasingly visible in global pharmaceutical development, yet their long-term international approval trajectory remains insufficiently characterised. This study examined the evolution of CDD approvals across major regulatory markets from 1990 to 2025, using the USA as the primary analytical anchor and Europe and other international markets as comparative and contextual settings. METHODS: We conducted a retrospective longitudinal descriptive study using regulatory approval records from the MENET database, supplemented by publicly available

Drug Repositioning for COVID-19.

Drug repositioning is a strategy that identifies new uses of approved drugs to treat conditions different from their original purpose. With the advance of COVID-19 and the pandemic declaration; It has become the closest alternative to reduce the advance of the virus. Antimalarial, antiviral drugs, antibiotics, glucocorticoids, monoclonal antibodies, among others, are being studied; their findings, although preliminary, could establish a starting point in the search for a solution. In this review, we present a selection of drugs, of different classes and with potential activity against COVID-19

[Levothyroxine and the problem of interchangeability of drugs with narrow therapeutic index].

The exchange of a prescribed drug by other similar, by generic products and even by custom products has become common practice in our country, often ignoring basic tenets of bioequivalence, interchangeability, stability and characteristics of the pharmaceutical compounds. In the case of drugs of narrow therapeutic index, such as levothyroxine, these problems are intensified, putting the effectiveness of treatment and patient health at serious risk. We review the pertinent legislation, emphasizing the characteristics of levothyroxine and adverse effects that limit the interchangeability of the

An Automated Capillary Electrophoresis Based Method for Drug Release Profiling of Liposomal Doxorubicin.

Liposomal doxorubicin hydrochloride is an antineoplastic agent widely used against human cancers. The data from in vitro drug release test (IVRT) is essential for quality and/or bioequivalence evaluation in drug approval and post-approval regulation of liposomal drug products. However, most of the currently available IVRT methods for liposomal doxorubicin hydrochloride have experimental deficiencies associated with liposomal rupture during the separation process which is needed for selective quantification of released drug from liposomal-bound drug. In addition, many of the methods are time co…

Stiripentol for the treatment of seizures in Dravet syndrome.

Dravet syndrome is an early childhood-onset epilepsy syndrome characterized by drug-resistant seizures, frequent episodes of status epilepticus, and the development of neurocognitive impairment. Seizure freedom in this condition is rare and there is a higher rate of sudden unexplained death in epilepsy patients (SUDEP) than other epilepsy syndromes. Stiripentol is a recently approved medication with an indication specifically for the treatment of seizures in children with Dravet syndrome. Areas covered: Review of relevant literature including the current and emerging treatment of seizures in c

Drug treatment of obesity in the cardiovascular patient.

PURPOSE OF REVIEW: The incidence of obesity and its associated comorbidities have significantly increased over the years with adverse health and financial consequences for society. Lifestyle changes are essential for the prevention and treatment of obesity but their benefit appears limited as inadequate and nonsustained weight loss results have been reported. Pharmacotherapy is frequently advocated as part of a weight loss strategy. In this review, we will discuss the antiobesity drugs with Food and Drug Administration approval and their cardiovascular implications. RECENT FINDINGS: Orlistat