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Jairia Dela Cruz, 6 days ago
The potassium-competitive acid blocker vonoprazan demonstrates superior efficacy in the treatment of patients with erosive oesophagitis compared with the proton pump inhibitor lansoprazole, with the results of a small trial showing that the former more rapidly provides complete sustained heartburn relief during the first week of therapy.
01 Mar 2016
Bathing with 2% chlorhexidine gluconate-medicated washcloth is cost-effective for the prevention of central line-associated bloodstream infection (CLABSI), based on a systematic review and meta-analysis of four studies.
Rachel Soon, 12 Dec 2018

MIMS Pharmacist presents an overview of superoxide dismutase (SOD) and its role in resisting the effects of oxidative stress and aging.

01 Mar 2018
Lifetime prevalence of acute pain leading to the use of analgesics approaches 100% in the general population, and pharmacists are a pivotal first point of contact for patients in their journey to better pain management. Noting the need for pharmacists to be more aware of their evolving role as a community pharmacist, GlaxoSmithKline Consumer Healthcare partnered with MIMS Education to organize a workshop that served as a platform for robust knowledge-sharing. Below are highlights from the workshop.

Original New Drug Application Approvals by US FDA (01 - 15 November 2018)

15 Nov 2018
New drug applications approved by US FDA as of 01 - 15 November 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.

SYMPAZAN
  • Active Ingredient(s): Clobazam
  • Strength: Not available
  • Dosage Form(s) / Route(s): Film; Oral
  • Company: Aquestive Therapeutics
  • Approval Date: 01 Nov 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
  • Approved Label01 Nov 2018 (PDF)

DSUVIA
  • Active Ingredient(s): Sufentanil
  • Strength: 30 MCG
  • Dosage Form(s) / Route(s): Tablet; Sublingual
  • Company: AcelRX Pharma Inc
  • Approval Date: 02 Nov 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
  • Approved Label02 Nov 2018 (PDF)

LORBRENA
  • Active Ingredient(s): Lorlatinib
  • Strength: 25 MG; 100 MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Pfizer Inc
  • Approval Date: 02 Nov 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on 
    • Icrizotinib and at least one other ALK inhibitor for metastatic disease; or
    • alectinib as the first ALK inhibitor therapy for metastatic disease; or 
    • ceritinib as the first ALK inhibitor therapy for metastatic disease. 
  • Approved Label: 02 Nov 2018 (PDF)

UDENYCA
  • Active Ingredient(s): Pegfilgrastim-CBQV
  • Strength: 6 MG / 0.6 ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Coherus Biosciences Inc
  • Approval Date: 02 Nov 2018
  • Submission Classification: Not Available
  • Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia
  • Approved Label: 02 Nov 2018 (PDF)

JEMDEL
  • Active Ingredient(s): Halobetasol Propionate
  • Strength: Not Available
  • Dosage Form(s) / Route(s): Not Available
  • Company: Dow Pharm
  • Approval Date: 06 Nov 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the topical treatment of plaque psoriasis in adults
  • Approved Label: 06 Nov 2018 (PDF)

PRIMATENE MIST
  • Active Ingredient(s): Epinephrine
  • Strength: 125 MCG
  • Dosage Form(s) / Route(s): Aerosol; Inhalation
  • Company: Armstrong Pharms
  • Approval Date: 07 Nov 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the temporary relief of mild symptoms of intermittent asthma
  • Approved Label: 07 Nov 2018 (PDF)

YUPELRI
  • Active Ingredient(s): Revefenacin
  • Strength: 175 MCG / 3 ML
  • Dosage Form(s) / Route(s): Solution; Inhalation
  • Company: Theravance Biopharma
  • Approval Date: 09 Nov 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
  • Approved Label: 09 Nov 2018 (PDF)
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Most Read Articles
Jairia Dela Cruz, 6 days ago
The potassium-competitive acid blocker vonoprazan demonstrates superior efficacy in the treatment of patients with erosive oesophagitis compared with the proton pump inhibitor lansoprazole, with the results of a small trial showing that the former more rapidly provides complete sustained heartburn relief during the first week of therapy.
01 Mar 2016
Bathing with 2% chlorhexidine gluconate-medicated washcloth is cost-effective for the prevention of central line-associated bloodstream infection (CLABSI), based on a systematic review and meta-analysis of four studies.
Rachel Soon, 12 Dec 2018

MIMS Pharmacist presents an overview of superoxide dismutase (SOD) and its role in resisting the effects of oxidative stress and aging.

01 Mar 2018
Lifetime prevalence of acute pain leading to the use of analgesics approaches 100% in the general population, and pharmacists are a pivotal first point of contact for patients in their journey to better pain management. Noting the need for pharmacists to be more aware of their evolving role as a community pharmacist, GlaxoSmithKline Consumer Healthcare partnered with MIMS Education to organize a workshop that served as a platform for robust knowledge-sharing. Below are highlights from the workshop.