Most Read Articles
Pearl Toh, 27 Mar 2020
Every-two-month injections of the long-acting cabotegravir + rilpivirine were noninferior to once-monthly injections for virologic suppression at 48 weeks in people living with HIV*, according to the ATLAS-2M** study presented at CROI 2020 — thus providing a potential option with more convenient dosing.
Stephen Padilla, 6 days ago
Treatment with hydroxychloroquine appears to significantly reduce viral load in patients with the novel coronavirus disease (COVID-19), with its beneficial effects reinforced by adding azithromycin, results of a recent study have shown.
Elvira Manzano, 22 Nov 2017
A blood pressure (BP) reading of 130/80 mm Hg or higher is the ‘new high’ in the latest AHA/ACC* hypertension guidelines, a threshold that is tighter than the JNC 7** cutpoint of 140/90 mm Hg for stage 1 hypertension in the general population. The change will mean more patients being labelled with hypertension.
Audrey Abella, 27 Mar 2020
The angiotensin receptor blocker (ARB) losartan did not improve inflammation, T-cell immune recovery, or fibrotic activity among older persons living with HIV (PLHIV) and viral suppression, according to data presented at CROI 2020.

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)
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Most Read Articles
Pearl Toh, 27 Mar 2020
Every-two-month injections of the long-acting cabotegravir + rilpivirine were noninferior to once-monthly injections for virologic suppression at 48 weeks in people living with HIV*, according to the ATLAS-2M** study presented at CROI 2020 — thus providing a potential option with more convenient dosing.
Stephen Padilla, 6 days ago
Treatment with hydroxychloroquine appears to significantly reduce viral load in patients with the novel coronavirus disease (COVID-19), with its beneficial effects reinforced by adding azithromycin, results of a recent study have shown.
Elvira Manzano, 22 Nov 2017
A blood pressure (BP) reading of 130/80 mm Hg or higher is the ‘new high’ in the latest AHA/ACC* hypertension guidelines, a threshold that is tighter than the JNC 7** cutpoint of 140/90 mm Hg for stage 1 hypertension in the general population. The change will mean more patients being labelled with hypertension.
Audrey Abella, 27 Mar 2020
The angiotensin receptor blocker (ARB) losartan did not improve inflammation, T-cell immune recovery, or fibrotic activity among older persons living with HIV (PLHIV) and viral suppression, according to data presented at CROI 2020.