Most Read Articles
Audrey Abella, 15 May 2020
In adults with atrial fibrillation (AF) after percutaneous coronary intervention (PCI), dual therapy (direct oral anticoagulant [DOAC] + P2Y12 inhibitor) reduces the risk of bleeding compared with triple therapy (vitamin K antagonist [VKA] + DAPT* [aspirin and P2Y12 inhibitor]), a meta-analysis has shown. However, its effects on the risks of mortality and ischaemic endpoints** remain unclear.
09 May 2020
Use of aspirin during the implantation window of the menstrual cycle appears to increase fecundability, reveals a recent study.
Rachel Soon, 08 Apr 2020

Guidelines for local pharmacists on what actions to take during the COVID-19 pandemic have been issued by the Malaysian Pharmaceutical Society (MPS).

Pearl Toh, 26 Sep 2019
The Singapore Health Sciences Authority (HSA) has recalled eight brands of ranitidine products containing trace amounts of the nitrosamine impurity NDMA*, which is a potential human carcinogen.

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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Most Read Articles
Audrey Abella, 15 May 2020
In adults with atrial fibrillation (AF) after percutaneous coronary intervention (PCI), dual therapy (direct oral anticoagulant [DOAC] + P2Y12 inhibitor) reduces the risk of bleeding compared with triple therapy (vitamin K antagonist [VKA] + DAPT* [aspirin and P2Y12 inhibitor]), a meta-analysis has shown. However, its effects on the risks of mortality and ischaemic endpoints** remain unclear.
09 May 2020
Use of aspirin during the implantation window of the menstrual cycle appears to increase fecundability, reveals a recent study.
Rachel Soon, 08 Apr 2020

Guidelines for local pharmacists on what actions to take during the COVID-19 pandemic have been issued by the Malaysian Pharmaceutical Society (MPS).

Pearl Toh, 26 Sep 2019
The Singapore Health Sciences Authority (HSA) has recalled eight brands of ranitidine products containing trace amounts of the nitrosamine impurity NDMA*, which is a potential human carcinogen.