Most Read Articles
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

5 days ago
Vitamin D deficiency may be a contributing factor to the mortality rate among patients with the novel coronavirus disease (COVID-19), reports a new study.
Pearl Toh, 4 days ago
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
17 Nov 2020
Invasive fungal infections, particularly those caused by Candida species, are common in hospitalized, immunocompromised, or critically ill patients and are associated with considerable morbidity and mortality.

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

02 Sep 2020
New drug applications approved by US FDA as of 16 - 31 August 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.

CYSTADROPS
  • Active Ingredient(s): Cysteamine ophthalmic solution
  • Strength: EQ 0.37% base
  • Dosage Form(s) / Route(s): Solution/drops; ophthalmic
  • Company: Recordati Rare
  • Approval Date: 19 August 2020 
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.
  • Approved Label19 August 2020 (PDF)

PEMETREXED
  • Active Ingredient(s): Pemetrexed
  • Strength: 100 mg/4 mL (25 mg/mL); 500 mg/20 mL (25 mg/mL); 1 g/40 mL (25 mg/mL)
  • Dosage Form(s) / Route(s): Solution; intravenous
  • Company: Actavis LLC
  • Approval Date: 21 August 2020
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Not available
  • Approved Label: Not available

METHOTREXATE
  • Active Ingredient(s): Methotrexate
  • Strength: 5 g/50 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Accord Healthcare, Inc.
  • Approval Date: 24 August 2020
  • Submission Classification: Not available
  • Indication(s): Not available
  • Approved Label: Not available

WINLEVI
  • Active Ingredient(s): Clascoterone
  • Strength: 1 g
  • Dosage Form(s) / Route(s): Cream; topical
  • Company: Cassiopea SPA
  • Approval Date: 26 August 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Not available
  • Approved Label: Not available

XARACOLL
  • Active Ingredient(s): Bupivacaine HCl
  • Strength: 300 mg
  • Dosage Form(s) / Route(s): Implant; subcutaneous
  • Company: Innocoll Pharmaceuticals
  • Approval Date: 28 August 2020
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair.
  • Approved Label28 August 2020 (PDF)

SOGROYA
  • Active Ingredient(s): Sompacitan-beco
  • Strength: 10 mg/1.5 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Novo Nordisk, Inc.
  • Approval Date: 28 August 2020
  • Submission Classification: Not available
  • Indication(s): Not available
  • Approved Label: Not available
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Most Read Articles
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

5 days ago
Vitamin D deficiency may be a contributing factor to the mortality rate among patients with the novel coronavirus disease (COVID-19), reports a new study.
Pearl Toh, 4 days ago
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
17 Nov 2020
Invasive fungal infections, particularly those caused by Candida species, are common in hospitalized, immunocompromised, or critically ill patients and are associated with considerable morbidity and mortality.