Most Read Articles
Stephen Padilla, 03 Aug 2018
It appears that the two-dose AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18v) is the most cost-effective choice for lowering the burden of cervical cancer through universal mass vaccination for 12-year-old girls in Singapore from the perspective of the healthcare payer (MOH Singapore), according to a recent study.
25 Apr 2020
The human papillomavirus (HPV) DNA vaccine (GX-188E) is effective against HPV type 16/18–associated cervical intraepithelial neoplasia (CIN) 3, according to the results of a phase II trial.
Audrey Abella, 02 Jul 2020
The highly selective SGLT2 inhibitor bexagliflozin demonstrated significant efficacy and safety in controlling hyperglycaemia, weight, and blood pressure (BP) in patients with type 2 diabetes (T2D) who were at high risk of cardiovascular (CV) events, results of the BEST** trial have shown.
18 Jul 2019
In the treatment of patients with human papillomavirus-positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC), de-escalating dose and volume of radiotherapy (RT) or chemoradiotherapy (CRT) based on response to induction chemotherapy appears to positively affect oncologic outcomes and reduce toxicity, according to data from the phase II OPTIMA trial.

Original New Drug Application Approvals by US FDA (16 - 30 June 2020)

30 Jun 2020
New drug applications approved by US FDA as of 16 - 30 June 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.

TAZVERIK
  • Active Ingredient(s): Tazemetostat hydrobromide
  • Strength: 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Epizyme, Inc.
  • Approval Date: 18 June 2020
  • Submission Classification: Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
  • Indication(s): Indicated for the treatment of:
    • Adult and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
    • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test who have received at least 2 prior systemic therapies.
    • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
  • Approved Label18 June 2020 (PDF)

GIMOTI
  • Active Ingredient(s): Metoclopramide
  • Strength: 15 mg
  • Dosage Form(s) / Route(s): Spray; nasal
  • Company: Evoke Pharma, Inc.
  • Approval Date: 19 June 2020
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
  • Approved Label19 June 2020 (PDF)

FINTEPLA
  • Active Ingredient(s): Fenfluamine
  • Strength: 2.5 mg/mL
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Zogenix, Inc.
  • Approval Date: 25 June 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
  • Approved Label25 June 2020 (PDF)

MYCAPSSA   
  • Active Ingredient(s): Octreotide   
  • Strength: 20 mg   
  • Dosage Form(s) / Route(s): Capsule, delayed release; oral   
  • Company: Chiasma, Inc.   
  • Approval Date: 26 June 2020   
  • Submission Classification: Type 5 - New Formulation or New Manufacturer   
  • Indication(s): Not available
  • Approved Label: Not available

PHESGO   
  • Active Ingredient(s): Pertuzumab; trastuzumab; hyaluronidase-zzxf   
  • Strength: 1,200 mg; 600 mg; 30,000 units   
  • Dosage Form(s) / Route(s): Injectable; intravenous, subcutaneous   
  • Company: Genentech, Inc.   
  • Approval Date: 29 June 2020   
  • Submission Classification: Not available   
  • Indication(s): Not available
  • Approved Label: Not available 

NITROGEN, NF
  • Active Ingredient(s): Nitrogen   
  • Strength: Not available   
  • Dosage Form(s) / Route(s): Gas; inhalation   
  • Company: Air Liquide Canada, Inc.   
  • Approval Date: 29 June 2020   
  • Submission Classification: Not available   
  • Indication(s): Not available   
  • Approved Label: Not available
DOJOLVI   
  • Active Ingredient(s): Triheptanoin   
  • Strength: 35%   
  • Dosage Form(s) / Route(s): Liquid; oral   
  • Company: Ultragenyx Pharm, Inc.   
  • Approval Date: 30 June 2020   
  • Submission Classification: Type 1 - New Molecular Entity  
  • Indication(s): Indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).
  • Approved Label30 June 2020 (PDF)
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Most Read Articles
Stephen Padilla, 03 Aug 2018
It appears that the two-dose AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18v) is the most cost-effective choice for lowering the burden of cervical cancer through universal mass vaccination for 12-year-old girls in Singapore from the perspective of the healthcare payer (MOH Singapore), according to a recent study.
25 Apr 2020
The human papillomavirus (HPV) DNA vaccine (GX-188E) is effective against HPV type 16/18–associated cervical intraepithelial neoplasia (CIN) 3, according to the results of a phase II trial.
Audrey Abella, 02 Jul 2020
The highly selective SGLT2 inhibitor bexagliflozin demonstrated significant efficacy and safety in controlling hyperglycaemia, weight, and blood pressure (BP) in patients with type 2 diabetes (T2D) who were at high risk of cardiovascular (CV) events, results of the BEST** trial have shown.
18 Jul 2019
In the treatment of patients with human papillomavirus-positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC), de-escalating dose and volume of radiotherapy (RT) or chemoradiotherapy (CRT) based on response to induction chemotherapy appears to positively affect oncologic outcomes and reduce toxicity, according to data from the phase II OPTIMA trial.