Most Read Articles
3 days ago
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Pank Jit Sin, 14 Apr 2020
With the movement control order (MCO) in full gear, most conferences and meetings are being postponed or cancelled. Some have taken to having conferences and meetings in a virtual setting, such as the recently ended American College of Cardiology/World Congress of Cardiology (ACC.20/WCC) conference. MIMS and the Asian Young Pharmacist Group (AYPG) took this opportunity to engage with pharmacists in the form of a Zoom meeting. 

Original New Drug Application Approvals by US FDA (16 - 31 May 2019)

31 May 2019
New drug applications approved by US FDA as of 16 - 31 May 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.

NAYZILAM
  • Active Ingredient(s): Midazolam
  • Strength: 5 mg/0.5 mL
  • Dosage Form(s) / Route(s): Spray; nasal
  • Company: Proximagen, LLC
  • Approval Date: 17 May 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizure) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. 
  • Approved Label17 May 2019 (PDF)

SLYND
  • Active Ingredient(s): Drospirenone
  • Strength: 4 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Exeltis USA, Inc.
  • Approval Date: 23 May 2019
  • Submission Classification: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
  • Indication(s): Indicated for use by females of reproductive potential to prevent pregnancy. 
  • Approved Label23 May 2019 (PDF)

PIQRAY
  • Active Ingredient(s): Alpelisib
  • Strength: 50 mg; 150 mg; 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Novartis Pharms Corp
  • Approval Date: 24 May 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
  • Approved Label24 May 2019 (PDF)
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Most Read Articles
3 days ago
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Pank Jit Sin, 14 Apr 2020
With the movement control order (MCO) in full gear, most conferences and meetings are being postponed or cancelled. Some have taken to having conferences and meetings in a virtual setting, such as the recently ended American College of Cardiology/World Congress of Cardiology (ACC.20/WCC) conference. MIMS and the Asian Young Pharmacist Group (AYPG) took this opportunity to engage with pharmacists in the form of a Zoom meeting.