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Chronic pancreatitis patients taking antioxidants (AO) supplementation show a sustained increase in blood levels of AO, but no additional benefit is seen on endocrine and exocrine functions, markers of fibrosis, oxidative stress (OS) and inflammation, nutritional status, pain, and quality of life (QOL) when compared with those on placebo, according to a study.
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Stephen Padilla, 13 Feb 2020
A pharmacist intervention appears to be effective in lowering and preventing the incidence of prescribing errors of investigational drugs in oncology clinical trials, a recent study has shown.

Original New Drug Application Approvals by US FDA (15 - 31 December 2018)

31 Dec 2018
New drug applications approved by US FDA as of 15 - 31 December 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.

EZALLORT
  • Active Ingredient(s): Rosuvastatin
  • Strength: 5 MG; 10 MG; 20 MG; 40 MG
  • Dosage Form(s) / Route(s): Capsul; Oral
  • Company: Sun Pharma Global
  • Approval Date: 18 Dec 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • adult patients with hypertriglyceridemia as an adjunct to diet; 
    • adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet;
    • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB.
  • Approved Label: 18 Dec 2018 (PDF)
LICART
  • Active Ingredient(s): Diclofenac epolamine
  • Strength: 1.3%
  • Dosage Form(s) / Route(s): Shampoo; Topical
  • Company: Institut Biochemique
  • Approval Date: 19 Dec 2018
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions
  • Approved Label: 19 Dec 2018 (PDF)
ELEPSIA XR
  • Active Ingredient(s): Levetiracetam
  • Strength: 1000MG; 1500MG
  • Dosage Form(s) / Route(s): Tablet, extended release; Oral
  • Company: Sun Pharma Global
  • Approval Date: 20 Dec 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older
  • Approved Label: 20 Dec 2018 (PDF)
ASPARLAS
  • Active Ingredient(s): Calaspargase pegol - mknl
  • Strength: 3750UNITS/5ML
  • Dosage Form(s) / Route(s): Injectable; Intravenous
  • Company: Servier Pharma LLC
  • Approval Date: 20 Dec 2018
  • Submission Classification: Not available
  • Indication(s): Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 year
  • Approved Label: 20 Dec 2018 (PDF)
INBRIJA
  • Active Ingredient(s): Levodopa
  • Strength: 42MG
  • Dosage Form(s) / Route(s): Powder; Inhalation
  • Company: Acorda
  • Approval Date: 21 Dec 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa
  • Approved Label: 21 Dec 2018 (PDF)
ULTOMIRIS
  • Active Ingredient(s): Ravulizumab-cwv
  • Strength: 300MG/30ML (10MG/ML) 
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Alexion Pharm
  • Approval Date: 21 Dec 2018
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
  • Approved Label: 21 Dec 2018 (PDF)
ELZONRIS
  • Active Ingredient(s): Tagraxofusp-erzs
  • Strength: 1000MCG
  • Dosage Form(s) / Route(s): Solution; Injection
  • Company: Stemline Therapeutics Inc
  • Approval Date: 21 Dec 2018
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older
  • Approved Label: 21 Dec 2018 (PDF)
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Most Read Articles
6 days ago
Chronic pancreatitis patients taking antioxidants (AO) supplementation show a sustained increase in blood levels of AO, but no additional benefit is seen on endocrine and exocrine functions, markers of fibrosis, oxidative stress (OS) and inflammation, nutritional status, pain, and quality of life (QOL) when compared with those on placebo, according to a study.
29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
01 Dec 2019
Pneumonia is a common infection– affecting around 3,200 people inSingapore in 2016 – making it the thirdmost common cause of hospitalisation inthe country. Its common complications,especially with delayed or inappropriatetreatment, include bacteraemia andseptic shock, lung abscesses, pleuraleffusions, empyema, pleurisy, respiratoryfailure and renal failure.
Stephen Padilla, 13 Feb 2020
A pharmacist intervention appears to be effective in lowering and preventing the incidence of prescribing errors of investigational drugs in oncology clinical trials, a recent study has shown.