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

15 Mar 2017
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)
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Most Read Articles
Jairia Dela Cruz, 30 Aug 2019
Infection with hepatitis B virus (HBV) does not appear to independently affect pregnancy outcomes, although it contributes to prolonged infertility, higher odds of secondary infertility, ovulatory disorders and reduced implantation rate, a study has found.
Dr. Joseph Delano Fule Robles, 23 Jan 2019

Scientists from the Department of Microbiology, University of Hong Kong (HKU) recently discovered a compound with broad antiviral activity against viruses causing Middle East Respiratory Syndrome (MERS), avian flu (H7N9), severe acute respiratory syndrome (SARS) and Zika fever.