Most Read Articles
Elaine Soliven, 4 days ago

Switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) to the new bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) regimen maintained high rates of virological suppression in adults who are living with HIV*, according to a study presented at AIDS 2020.

2 days ago
Among individuals with abdominal obesity, drinking beverages with artificial sweeteners (ASBs) or no sugar (USBs) instead of sugar-sweetened beverages (SSBs) helps lose body weight, a study has found. However, USBs have a more favourable effect on sweet taste preference compared with ASBs.
Stephen Padilla, 4 days ago
Pre-exposure prophylaxis (PrEP) containing either long-acting injectable cabotegravir (CAB) or tenofovir/emtricitabine (TDF/FTC) is safe and effective for transgender women (TGW) and cisgender men who have sex with men (MSM), but CAB results in a much lower HIV incidence compared to TDF/FTC, results of the HIV Prevention Trials Network (HPTN) 083 have shown.
Jairia Dela Cruz, 3 days ago
Monthly prophylaxis with the fixed-dose combination of naphthoquine-azithromycin (NQAZ) is well tolerated and confers significant protection against infection with Plasmodium parasites among individuals residing in malaria-endemic areas in Southeast Asia, as shown in the results of a phase III trial.

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

02 Jul 2019
New drug applications approved by US FDA as of 16 - 30 June 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.

MYXREDLIN
  • Active Ingredient(s): Insulin human; sodium chloride
  • Strength:  100 mL; 9%
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Celerity Pharms
  • Approval Date: 20 June 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
  • Approved Label20 June 2019 (PDF)

VYLEESI
  • Active Ingredient(s): Bremelanotide acetate
  • Strength: 1.75 mg/0.3 mL
  • Dosage Form(s) / Route(s): Injectable; intravenous, subcutaneous
  • Company: Amag Pharms, Inc.
  • Approval Date: 21 June 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
    • A co-existing medical or psychiatric condition,
    • Problems with the relationship, or
    • The effects of a medication or drug substance.
  • Approved Label21 June 2019 (PDF)

ZIRABEV
  • Active Ingredient(s): Bevacizumab-bvzr
  • Strength: 100 mg/4 mL; 400 mg/16 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pfizer, Inc.
  • Approval Date: 27 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of:
    • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
    • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
  • Approved Label27 June 2019 (PDF)

THIOLA EC
  • Active Ingredient(s): Tiopronin
  • Strength: 100 mg; 300 mg
  • Dosage Form(s) / Route(s): Tablet, delayed release; oral
  • Company: Mission Pharmacal Co.
  • Approval Date: 28 June 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Doctor - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Elaine Soliven, 4 days ago

Switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) to the new bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) regimen maintained high rates of virological suppression in adults who are living with HIV*, according to a study presented at AIDS 2020.

2 days ago
Among individuals with abdominal obesity, drinking beverages with artificial sweeteners (ASBs) or no sugar (USBs) instead of sugar-sweetened beverages (SSBs) helps lose body weight, a study has found. However, USBs have a more favourable effect on sweet taste preference compared with ASBs.
Stephen Padilla, 4 days ago
Pre-exposure prophylaxis (PrEP) containing either long-acting injectable cabotegravir (CAB) or tenofovir/emtricitabine (TDF/FTC) is safe and effective for transgender women (TGW) and cisgender men who have sex with men (MSM), but CAB results in a much lower HIV incidence compared to TDF/FTC, results of the HIV Prevention Trials Network (HPTN) 083 have shown.
Jairia Dela Cruz, 3 days ago
Monthly prophylaxis with the fixed-dose combination of naphthoquine-azithromycin (NQAZ) is well tolerated and confers significant protection against infection with Plasmodium parasites among individuals residing in malaria-endemic areas in Southeast Asia, as shown in the results of a phase III trial.