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Jairia Dela Cruz, 2 days ago
In patients with heart failure with reduced ejection fraction (HFrEF) receiving angiotensin-converting-enzyme (ACE) inhibitors, high dosing confers benefits for the risk of death or hospitalization that are similar to that obtained with lower dosing, according to a systematic review and meta-analysis.
11 Sep 2020
Men who use calcium channel blockers (CCBs) are at risk of developing prostate cancer, and the risk increases with the duration of CCB exposure, according to the results of a systematic review and meta-analysis.
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Type 2 diabetes mellitus patients taking proton pump inhibitors (PPIs) are at a higher risk of sustaining hip fractures, a recent study has found.
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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
Jairia Dela Cruz, 2 days ago
In patients with heart failure with reduced ejection fraction (HFrEF) receiving angiotensin-converting-enzyme (ACE) inhibitors, high dosing confers benefits for the risk of death or hospitalization that are similar to that obtained with lower dosing, according to a systematic review and meta-analysis.
11 Sep 2020
Men who use calcium channel blockers (CCBs) are at risk of developing prostate cancer, and the risk increases with the duration of CCB exposure, according to the results of a systematic review and meta-analysis.
06 Sep 2020
Type 2 diabetes mellitus patients taking proton pump inhibitors (PPIs) are at a higher risk of sustaining hip fractures, a recent study has found.
4 days ago
Osteoarthritis (OA) is the most common condition affecting the joints. Dr Lee Eu Jin, an Orthopaedic Surgeon from Liberty Orthopaedic Clinic at Mount Elizabeth Medical Centre, Singapore, shares his insights with Pearl Toh on how to manage OA in the primary care setting.