Most Read Articles
Rachel Soon, 12 Dec 2018

MIMS Pharmacist speaks to Cpt. Manvikram Singh Gill, military pharmacist with the Royal Medical and Dental Corps (RMDC) of the Malaysian Armed Forces (MAF),about his work at the Rohingya refugee camp in Cox's Bazar, Bangladesh.

Ms Penny Wong Pei Nee, 12 Jul 2018
Antibiotics, also known as antibacterials, are a group of medications that either destroy the infecting bacteria or slow down their growth.
Elaine Soliven, 30 Jun 2020
Treatment with Lactobacillus crispatus CTV-05 (Lactin-V) significantly reduces the incidence of bacterial vaginosis recurrence in women who were previously treated with vaginal metronidazole, according to a recent study.
Jairia Dela Cruz, 20 May 2020
Concomitant use of fimasartan and rosuvastatin in patients with hypertension and dyslipidaemia does not appear to be synergistic in increasing concurrent control rate of the diseases, although either drug is effective against the target disease, according to a study.

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)
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
Rachel Soon, 12 Dec 2018

MIMS Pharmacist speaks to Cpt. Manvikram Singh Gill, military pharmacist with the Royal Medical and Dental Corps (RMDC) of the Malaysian Armed Forces (MAF),about his work at the Rohingya refugee camp in Cox's Bazar, Bangladesh.

Ms Penny Wong Pei Nee, 12 Jul 2018
Antibiotics, also known as antibacterials, are a group of medications that either destroy the infecting bacteria or slow down their growth.
Elaine Soliven, 30 Jun 2020
Treatment with Lactobacillus crispatus CTV-05 (Lactin-V) significantly reduces the incidence of bacterial vaginosis recurrence in women who were previously treated with vaginal metronidazole, according to a recent study.
Jairia Dela Cruz, 20 May 2020
Concomitant use of fimasartan and rosuvastatin in patients with hypertension and dyslipidaemia does not appear to be synergistic in increasing concurrent control rate of the diseases, although either drug is effective against the target disease, according to a study.