Most Read Articles
26 Dec 2017
Supplementation with omega-3 fatty acids in combination with rosuvastatin may yield significant reductions in triglycerides and nonhigh-density lipoprotein (HDL) cholesterol as compared with rosuvastatin monotherapy, according to data from the ROMANTIC (rosuvastatin-omacor in residual hypertriglyceridemia) trial.
Elaine Soliven, 20 May 2020
Early treatment with a triple antiviral combination of lopinavir-ritonavir, ribavirin, and interferon beta-1b significantly shortens the duration of virus shedding and reduces symptoms in patients with mild-to-moderate COVID-19 compared with lopinavir-ritonavir only, according to a recent study.
Rachel Soon, 24 Apr 2019

With recent recalls of losartan-containing products contaminated by potentially carcinogenic nitrosamines, MIMS speaks to the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for more details.

Elaine Soliven, 24 Feb 2020
Administering intravenous propranolol hydrochloride does not reduce the duration of labour induction for nulliparous women who undergo vaginal delivery, according to a study presented at SMFM 2020.

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

31 Mar 2020
New drug applications approved by US FDA as of 16 - 31 March 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.

PULMOTECH MAA
  • Active Ingredient(s): Technetium TC99M albumin aggregated
  • Strength: 2 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: CIS BIO Intl.
  • Approval Date: 20 March 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adult and pediatric patients.
    • Scintigraphy of peritoneovenous shunt as an aid in the evaluation of its patency in adults.
  • Approved Label20 March 2020 (PDF)

ZEPOSIA
  • Active Ingredient(s): Ozanimod hydrochloride
  • Strength: 0.23 mg; 0.46 mg; 0.92 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Celgene
  • Approval Date: 25 March 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • Approved Label25 March 2020 (PDF)

TRIFERIC
  • Active Ingredient(s): Ferric pyrophosphate citrate
  • Strength: 6.75 mg iron per 4.5 mL solution
  • Dosage Form(s) / Route(s): Solution; intravenous
  • Company: Rockwell Medical Inc.
  • Approval Date: 27 March 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
  • Approved Label27 March 2020 (PDF)

LEVONORGESTREL AND ETHINYL ESTRADIOL
  • Active Ingredient(s): Ethinyl estradiol; levonorgestrel
  • Strength: 0.01 mg/0.02 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Exeltis USA, Inc.
  • Approval Date: 30 March 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available
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Editor's Recommendations
Most Read Articles
26 Dec 2017
Supplementation with omega-3 fatty acids in combination with rosuvastatin may yield significant reductions in triglycerides and nonhigh-density lipoprotein (HDL) cholesterol as compared with rosuvastatin monotherapy, according to data from the ROMANTIC (rosuvastatin-omacor in residual hypertriglyceridemia) trial.
Elaine Soliven, 20 May 2020
Early treatment with a triple antiviral combination of lopinavir-ritonavir, ribavirin, and interferon beta-1b significantly shortens the duration of virus shedding and reduces symptoms in patients with mild-to-moderate COVID-19 compared with lopinavir-ritonavir only, according to a recent study.
Rachel Soon, 24 Apr 2019

With recent recalls of losartan-containing products contaminated by potentially carcinogenic nitrosamines, MIMS speaks to the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for more details.

Elaine Soliven, 24 Feb 2020
Administering intravenous propranolol hydrochloride does not reduce the duration of labour induction for nulliparous women who undergo vaginal delivery, according to a study presented at SMFM 2020.