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20 Aug 2015
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Levels of the proinflammatory cytokline interleukin-18 (IL-18) appear to be significantly increased in patients with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection compared with those who have either infection, according to a study.

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)
Editor's Recommendations
Most Read Articles
20 Aug 2015
Intralesional vitamin D3 injection may be an effective treatment alternative for plantar warts as demonstrated in a study.
06 May 2015

Antigenic seniority and cross-reactivity are important determinants of host immunity against seasonal influenza viruses, according to a recent study.


Pearl Toh, 13 Feb 2017
Atopic dermatitis (AD) during infancy is associated with an increased risk of developing tooth decay by age three, according to results from the GUSTO* study.
02 Mar 2017
Levels of the proinflammatory cytokline interleukin-18 (IL-18) appear to be significantly increased in patients with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection compared with those who have either infection, according to a study.