Most Read Articles
Dr. Carol Tan, 2 years ago
A novel vaccine against dengue has been found to be effective and safe, based on a randomized controlled trial conducted by Dr Maria Rosario Capedeng, et al.
one year ago
Peak nasal inspiratory flow is as favourable as formal rhinomanometry as a marker of objective nasal patency but is cheaper, simpler, and more appropriate for serial measurements and home use according to a review.
Pank Jit Sin, one year ago
The launch of the first dengue vaccine is expected to be underway in Malaysia, with regulatory processes being the remaining hurdle in its release. 
one year ago
New drug applications approved by US FDA as of 15 – 30 June 2015 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.

Original New Drug Application Approvals by US FDA (1 - 15 March 2017)

3 months ago
New drug applications approved by US FDA as of 1 - 15 March 2017 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.

EPHEDRINE SULFATE
  • Active Ingredient(s): EPHEDRINE SULFATE
  • Strength: 50MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Akorn Inc
  • Approval Date: March 1, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia
  • Approved Label: 03/01/2017 (PDF)

NOCTIVA
  • Active Ingredient(s): DESMOPRESSIN ACETATE
  • Strength: 0.83MCG/0.1ML; 1.66MCG/0.1ML
  • Dosage Form: Nasal Spray
  • Company: Serenity Pharms LLC
  • Approval Date: March 3, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void
  • Approved Label: 03/03/2017 (PDF)

NIPRIDE RTU
  • Active Ingredient(s): SODIUM NITROPRUSSIDE;SODIUM CHLORIDE
  • Strength: 0.5MG/ML;9%
  • Dosage Form: Injectable; Injection
  • Company: Exela Pharma Science
  • Approval Date: March 3, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • Immediate reduction of blood pressure
    • Producing controlled hypotension to reduce bleeding during surgery
    • Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure
  • Approved Label: 03/03/2017 (PDF)

VORICONAZOLE
  • Active Ingredient(s): VORICONAZOLE
  • Strength: 200MG
  • Dosage Form: Injectable; Injection
  • Company: Xellia Pharms APS
  • Approval Date: March 9, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for use in the treatment of:
    • Invasive aspergillosis
    • Candidemia (nonneutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds
    • Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy
  • Approved Label: 03/09/2017 (PDF)

KISQALI
  • Active Ingredient(s): RIBOCICLIB
  • Strength: 200MG
  • Dosage Form: Oral tablet
  • Company: Novartis Pharms Corp
  • Approval Date: March 13, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
  • Approved Label: 03/13/2017 (PDF)
Editor's Recommendations
Most Read Articles
Dr. Carol Tan, 2 years ago
A novel vaccine against dengue has been found to be effective and safe, based on a randomized controlled trial conducted by Dr Maria Rosario Capedeng, et al.
one year ago
Peak nasal inspiratory flow is as favourable as formal rhinomanometry as a marker of objective nasal patency but is cheaper, simpler, and more appropriate for serial measurements and home use according to a review.
Pank Jit Sin, one year ago
The launch of the first dengue vaccine is expected to be underway in Malaysia, with regulatory processes being the remaining hurdle in its release. 
one year ago
New drug applications approved by US FDA as of 15 – 30 June 2015 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.