Article

First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA

2022-01-18

Abstract excerpt

<title>Abstract</title> <p>The Ministry of Health, Labour and Welfare (MHLW) in Japan approved the first generic version of Nasonex in February 2018. The Pharmaceuticals and Medical Devices Agency requires <italic>in vitro</italic>, pharmacokinetic, and pharmacodynamic or clinical endpoint data to approve generic nasal spray drug products. However, the MHLW has not published basic principle for approving nasal ge...

Topics

Open a Topic to create a Post that cites this publication.

Identifiers and source

Literature Corpus work: 26f29893-5edc-5d0f-878b-79d9cf9ac596
DOI: 10.21203/rs.3.rs-1200976/v1

Open publication

Related research

Semantic proximity does not establish scientific evidence.

Click a neighbor to travelStep 1 · 12 closest

First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USADOI 10.21203/rs.3.rs-1200976/v1Read

Zavegepant intranasal spray for the Acute Treatment of Migraine : A Systematic Review and Meta-Analysis of Randomized Clinical TrialsSemantic proximity Read

Identifying Factors Associated with the Efficacy of Lasmiditan 50 mg as an Acute Treatment for Migraine Attacks Under Various Dosing Conditions in Real-World Clinical PracticeSemantic proximity Read

Clinical pharmacokinetic registration file for NDA and ANDA procedures.Semantic proximity Read

Comparison of intravenous nabuphine and dexmedetomidine in combination with lidocaine aerosol inhalation in awake direct laryngoscopy: a randomized, double-blind, placebo-controlled trialSemantic proximity Read

Parenteral Ready-to-Use Fixed-Dose Combinations of NSAIDs for Multimodal Analgesia – An overview of approved products and challengesSemantic proximity Read

Expert Consensus on the Use of Diphenhydramine for Short-Term Insomnia: Efficacy, Safety and Clinical ApplicationsSemantic proximity Read

International Regulations for Bioequivalence Approval of Locally Acting Orally Inhaled Drug ProductsSemantic proximity Read

Proving equivalence of originator and an authorized generic drug following EMA draft guideline on quality and equivalence of topical productsSemantic proximity Read

Omalizumab for the Treatment of Allergic Rhinitis: A Systematic Review and Meta-AnalysisSemantic proximity Read

Enhancing Acute Migraine Treatment: Exploring Solid Lipid Nanoparticles and Nanostructured Lipid Carriers for the Nose-to-Brain RouteSemantic proximity Read

Advancements in Drug Delivery Systems from Chewable Tablets to NanomedicineSemantic proximity Read

Newer-generation antihistamines and the risk of adverse events in children: a systematic reviewSemantic proximity Read