Most Read Articles
Stephen Padilla, Yesterday
The use of povidone iodine (PI) is more effective than chlorhexidine gluconate (CHG) at reducing vaginal bacterial colony counts in pregnancy and appears to be a superior vaginal antiseptic for decreasing postpartum infections, according to a study presented at the 2020 Annual Meeting of the Society for Maternal-Fetal Medicine (SMFM 2020).
Prof. Vincent Wong, Prof. Ray Kim, Dr. Tan Poh Seng, 10 Sep 2019
Chronic hepatitis B (CHB) remains a major public health concern because of its worldwide distribution and potential adverse sequelae, including cirrhosis and hepatocellular carcinoma (HCC). At a recent symposium held during the GIHep Singapore 2019, Professor Vincent Wong from the Chinese University of Hong Kong and Professor Ray Kim from the Stanford University School of Medicine, Stanford, California, US, discussed antiviral treatments for CHB, with a focus on the novel agent tenofovir alafenamide (Vemlidy®). Dr Tan Poh Seng from the National University Hospital, Singapore, chaired the symposium.
Audrey Abella, 23 Jan 2019
A single infusion of the monoclonal antibody rituximab temporarily delays the clinical onset of rheumatoid arthritis (RA) through B-cell depletion, underpinning the preventive potential of rituximab in RA development especially in high-risk individuals, according to the PRAIRI* study.
26 Nov 2019
Podcast: Professor R. Scott Wright speaks about the potential role of inclisiran in providing durable reductions in LDL-cholesterol levels in patients with atherosclerotic cardiovascular disease.

Original New Drug Application Approvals by US FDA (16 - 31 January 2020)

31 Jan 2020
New drug applications approved by US FDA as of 16 - 31 January 2020 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.

MONOFERRIC
  • Active Ingredient(s): Ferric derisomaltose
  • Strength: 100 mg/mL; 500 mg/5 mL; 1,000 mg/10 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pharmacosmos As
  • Approval Date: 16 January 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of iron deficiency anemia in adult patients:
    • who have intolerance to oral iron or have had unsatisfactory response to oral iron.
    • who have non-hemodialysis dependent chronic kidney disease.
  • Approved Label16 January 2020 (PDF)

RYBELSUS
  • Active Ingredient(s): Semaglutide
  • Strength: 3 mg; 7 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Novo Nordisk, Inc.
  • Approval Date: 16 January 2020
  • Submission Classification:Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
  • Indication(s): Indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Approved Label16 January 2020 (PDF)

TEPEZZA
  • Active Ingredient(s): Teprotumumab-trbw
  • Strength: 500 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Horizon Therapeutics Ireland
  • Approval Date: 21 January 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of Thyroid Eye Disease.
  • Approved Label21 January 2020 (PDF)

TAZVERIK
  • Active Ingredient(s): Tazemetostat
  • Strength: 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Epizyme, Inc.
  • Approval Date: 23 January 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Approved Label23 January 2020 (PDF)

TRIJARDY XR
  • Active Ingredient(s): Empagliflozin; linagliptin; metformin hydrochloride
  • Strength: 25 mg; 5 mg; 2,000 mg
  • Dosage Form(s) / Route(s): Tablet, extended release; oral
  • Company: Boehringer Ingelheim
  • Approval Date: 27 January 2020
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Approved Label27 January 2020 (PDF)

BYNFEZIA PEN
  • Active Ingredient(s): Octreotide acetate
  • Strength: 100 mcg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Sun Pharm Inds, Ltd. 
  • Approval Date: 28 January 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • Reduction of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) [somatomedin C] in adult patients with acromegaly who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
    • Treatment of severe diarrhea/flushing episodes associated with metastatic carcinoid tumors in adult patients.
    • Treatment of profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas) in adult patients.
  • Approved Label28 January 2020 (PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Pharmacist - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Stephen Padilla, Yesterday
The use of povidone iodine (PI) is more effective than chlorhexidine gluconate (CHG) at reducing vaginal bacterial colony counts in pregnancy and appears to be a superior vaginal antiseptic for decreasing postpartum infections, according to a study presented at the 2020 Annual Meeting of the Society for Maternal-Fetal Medicine (SMFM 2020).
Prof. Vincent Wong, Prof. Ray Kim, Dr. Tan Poh Seng, 10 Sep 2019
Chronic hepatitis B (CHB) remains a major public health concern because of its worldwide distribution and potential adverse sequelae, including cirrhosis and hepatocellular carcinoma (HCC). At a recent symposium held during the GIHep Singapore 2019, Professor Vincent Wong from the Chinese University of Hong Kong and Professor Ray Kim from the Stanford University School of Medicine, Stanford, California, US, discussed antiviral treatments for CHB, with a focus on the novel agent tenofovir alafenamide (Vemlidy®). Dr Tan Poh Seng from the National University Hospital, Singapore, chaired the symposium.
Audrey Abella, 23 Jan 2019
A single infusion of the monoclonal antibody rituximab temporarily delays the clinical onset of rheumatoid arthritis (RA) through B-cell depletion, underpinning the preventive potential of rituximab in RA development especially in high-risk individuals, according to the PRAIRI* study.
26 Nov 2019
Podcast: Professor R. Scott Wright speaks about the potential role of inclisiran in providing durable reductions in LDL-cholesterol levels in patients with atherosclerotic cardiovascular disease.