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 (01 - 15 March 2020)

17 Mar 2020
New drug applications approved by US FDA as of 01 - 15 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.

SARCLISA
  • Active Ingredient(s): Isatuximab-irfc
  • Strength: 100 mg/5 mL (20 mg/mL); 500 mg/25 mL (20 mg/mL)
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Sanofi Aventis US
  • Approval Date: 02 March 2020
  • Submission Classification: Not available
  • Indication(s): Indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
  • Approved Label02 March 2020 (PDF)

DURYSTA
  • Active Ingredient(s): Bimatoprost
  • Strength: 10 mcg
  • Dosage Form(s) / Route(s): Implant; implantation
  • Company: Allergan
  • Approval Date: 04 March 2020 
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
  • Approved Label04 March 2020 (PDF)

ISTURISA
  • Active Ingredient(s): Osilodrostat
  • Strength: 1 mg; 5 mg; 10 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Novartis Pharms Corp
  • Approval Date: 06 March 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.
  • Approved Label06 March 2020 (PDF)

FLUORESCEIN SODIUM; BENOXINATE HYDROCHLORIDE
  • Active Ingredient(s): Fluorescein sodium; benoxinate hydrochloride
  • Strength: 0.3%; 0.4%
  • Dosage Form(s) / Route(s): Solution; ophthalmic
  • Company: Baush Health Ireland, Ltd.
  • Approval Date: 09 March 2020
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for procedures in adult and pediatric patients requiring a disclosing agent in combination with topical ophthalmic anesthetic.
  • Approved Label09 March 2020 (PDF)

ROMIDEPSIN
  • Active Ingredient(s): Romidepsin
  • Strength: 10 mg/2 mL; 27.5 mg/5.5 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Teva Pharms USA, Inc.
  • Approval Date: 13 March 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for: 
    • Treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.
    • Treatment of peripheral T-cell lymphoma (PTCL) in adult patients who have received at least one prior therapy. 
  • Approved Label13 March 2020 (PDF)
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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.