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Roshini Claire Anthony, 5 days ago

Beta-blockers could reduce mortality risk in patients with heart failure with reduced ejection fraction (HFrEF) and moderate or moderately-severe renal dysfunction without causing harm, according to the BB-META-HF* trial presented at ESC 2019.

Stephen Padilla, 6 days ago
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Original New Drug Application Approvals by US FDA (1 - 15 September 2018)

15 Sep 2018
New drug applications approved by US FDA as of 1 - 15 September 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

TIGLUTIK
  • Active Ingredient(s): Riluzole
  • Strength: 50MG/ML
  • Dosage Form(s)/Route(s): Suspension; Oral
  • Company: Italfarmaco SpA
  • Approval Date: 09 Sep 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS)
  • Approved Label: 09 Sep 2018 (PDF)
CASSIPA
  • Active Ingredient(s): Buprenorphine; Naloxone
  • Strength: 16MG; 4MG
  • Dosage Form(s)/Route(s): Film; Buccal, Sublingual
  • Company: Teva Pharms USA Inc
  • Approval Date: 07 Sep 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the maintenance treatment of opioid dependence
  • Approved Label: 07 Sep 2018 (PDF)
XELPROS
  • Active Ingredient(s): Lantanoprost
  • Strength: 0.005%
  • Dosage Form(s)/Route(s): Emulsion; Ophthalmic
  • Company: Sun Pharma Global
  • Approval Date: 12 Sep 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension
  • Approved Label: 12 Sep 2018 (PDF)
LUMOXITI
  • Active Ingredient(s): Moxetumomab pasudotox-tdfk
  • Strength: 1MG/VIAL
  • Dosage Form(s)/Route(s): Injectable; Injection
  • Company: AstraZeneca AB
  • Approval Date: 13 Sep 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA)
  • Approved Label: 13 Sep 2018 (PDF)
SEIZALAM
  • Active Ingredient(s): Midazolam
  • Strength: 5MG/ML
  • Dosage Form(s)/Route(s): Injectable; Injection
  • Company: Meridian Medical Techn.
  • Approval Date: 14 Sep 2018
  • Submission Classification: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
  • Indication(s): Not available
  • Approved Label: Not available
AJOVY
  • Active Ingredient(s): Fremanezumab-VFRM
  • Strength: 150MG/ML
  • Dosage Form(s)/Route(s): Injectable; Injection
  • Company: Teva Pharms USA
  • Approval Date: 14 Sep 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the preventive treatment of migraine in adults
  • Approved Label: 14 Sep 2018 (PDF)
Editor's Recommendations
Most Read Articles
Roshini Claire Anthony, 5 days ago

Beta-blockers could reduce mortality risk in patients with heart failure with reduced ejection fraction (HFrEF) and moderate or moderately-severe renal dysfunction without causing harm, according to the BB-META-HF* trial presented at ESC 2019.

Stephen Padilla, 6 days ago
Implementation of the collaborative care in a rheumatoid arthritis (RA) clinic has led to improvements in nonbiologic disease-modifying antirheumatic drugs (nb-DMARDs) optimization, adherence to safety recommendations on nb-DMARD monitoring and detection of adverse drug events in RA patients, according to a Singapore study.
5 days ago
Blood pressure (BP) in children is influenced by early-life exposure to several chemicals, built environment and meteorological factors, suggests a study.
5 days ago
Short sleep duration is associated with an increased risk of myocardial infarction (MI), according to prospective observational and Mendelian randomization (MR) analyses.