Most Read Articles
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).

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.
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.
Roshini Claire Anthony, 6 days ago

The use of a vaginal cleansing intervention prior to Caesarean delivery reduced the incidence of surgical site infections (SSIs), according to a study presented at ACOG 2020. However, the addition of intravenous (IV) azithromycin prophylaxis had no added impact on SSI rates. 

Original New Drug Application Approvals by US FDA (01 - 15 September 2019)

17 Sep 2019
New drug application approved by US FDA as of 01 - 15 September 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.

GVOKE
  • Active Ingredient(s): Glucagon
  • Strength: 0.5 mg; 1 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Xeris Pharma, Inc.
  • Approval Date: 10 September 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.
  • Approved Label10 September 2019 (PDF)

IBSRELA
  • Active Ingredient(s): Tenapanor
  • Strength: 50 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Ardelyx, Inc.
  • Approval Date: 12 September 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
  • Approved Label12 September 2019 (PDF)
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Most Read Articles
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).

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.
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.
Roshini Claire Anthony, 6 days ago

The use of a vaginal cleansing intervention prior to Caesarean delivery reduced the incidence of surgical site infections (SSIs), according to a study presented at ACOG 2020. However, the addition of intravenous (IV) azithromycin prophylaxis had no added impact on SSI rates.