Most Read Articles
01 Dec 2019
Macrolide antibiotics are derived from the Streptomycesspecies. These contain either 14-membered (erythromycin [ERM],clarithromycin [CAM], roxithromycin [RXM]), 15-membered(azithromycin [AZM]) or 16-membered (spiramycin, josamycin,midecamycin) macrocyclic lactone rings. They inhibit proteinsynthesis by reversibly binding to the 23S ribosomal RNA (rRNA)in the 50s subunit of the bacterial ribosome. Traditionally,macrolides are used as first-line agents in respiratory, skin,soft tissue, and urogenital infections, and they are also activeagainst gram-positive cocci and atypical pathogens.
29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
Jairia Dela Cruz, 4 days ago
Nonsmall cell lung cancer (NSCLC) patients harbouring sensitive EGFR mutations may fare well with the third-generation tyrosine kinase inhibitor osimertinib as an upfront therapy, with the results of a network meta-analysis showing that the drug tops other currently available options in terms of progression-free survival and tolerability.
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.

Original New Drug Application Approvals by US FDA (16 - 30 November 2019)

04 Dec 2019
New drug applications approved by US FDA as of 16 - 30 November 2019 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.

GIVLAARI
  • Active Ingredient(s): Givosiran sodium
  • Strength: 189 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Alnylam Pharms, Inc.
  • Approval Date: 20 November 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with acute hepatic porphyria (AHP).
  • Approved Label20 November 2019 (PDF)

XCOPRI
  • Active Ingredient(s): Cenobamate
  • Strength: 12.5 mg; 25 mg; 50 mg; 100 mg; 150 mg; 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: SK Life Science, Inc.
  • Approval Date: 21 November 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of partial-onset seizures in adult patients.
  • Approved Label21 November 2019 (PDF)

EXSERVAN
  • Active Ingredient(s): Riluzole
  • Strength: 50 mg
  • Dosage Form(s) / Route(s): Film; oral
  • Company: Aquestive Therap
  • Approval Date: 22 November 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS).
  • Approved Label22 November 2019 (PDF)

OXBRYTA
  • Active Ingredient(s): Voxelotor
  • Strength: 500 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Global Blood Therapeutics, Inc.
  • Approval Date: 25 November 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older.
  • Approved Label25 November 2019 (PDF)

POTASSIUM PHOSPHATES
  • Active Ingredient(s): Potassium phosphates
  • Strength: 3 mmol/mL; 4.4 mEq/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Fresenius Kabi USA
  • Approval Date: 26 November 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as a source of phosphorus:
    • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated.
    • for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.
  • Approved Label26 November 2019 (PDF)

REDITREX (METHOTREXATE) INJECTION
  • Active Ingredient(s): Methotrexate
  • Strength: 7.5 mg; 10 mg; 12.5 mg; 15 mg; 17.5 mg; 20 mg; 22.5 mg; 25 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Cumberland Pharms
  • Approval Date: 27 November 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the:
    • Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy.
    • Symptomatic control of sever, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.
  • Approved Label27 November 2019 (PDF)
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Most Read Articles
01 Dec 2019
Macrolide antibiotics are derived from the Streptomycesspecies. These contain either 14-membered (erythromycin [ERM],clarithromycin [CAM], roxithromycin [RXM]), 15-membered(azithromycin [AZM]) or 16-membered (spiramycin, josamycin,midecamycin) macrocyclic lactone rings. They inhibit proteinsynthesis by reversibly binding to the 23S ribosomal RNA (rRNA)in the 50s subunit of the bacterial ribosome. Traditionally,macrolides are used as first-line agents in respiratory, skin,soft tissue, and urogenital infections, and they are also activeagainst gram-positive cocci and atypical pathogens.
29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
Jairia Dela Cruz, 4 days ago
Nonsmall cell lung cancer (NSCLC) patients harbouring sensitive EGFR mutations may fare well with the third-generation tyrosine kinase inhibitor osimertinib as an upfront therapy, with the results of a network meta-analysis showing that the drug tops other currently available options in terms of progression-free survival and tolerability.
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.