Most Read Articles
13 Oct 2017
Use of systemic antibiotics, in conjunction with performance of incision and drainage, in the management of paediatric acute skin and soft tissue infection (SSTI) appears to reduce Staphylococcus aureus colonization and the likelihood of infection recurrence, a prospective study has found.
12 Oct 2017
Retreatment with ledipasvir and sofosbuvir with add-on ribavirin appears to be effective and well tolerated in genotype 1 hepatitis C virus (HCV)-infected patients who have failed to respond to daclatasvir/asunaprevir combination therapy, according to a study.
16 Oct 2017
Excessive intake of the mineral manganese can be toxic to the heart, according to a new 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)
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Most Read Articles
13 Oct 2017
Use of systemic antibiotics, in conjunction with performance of incision and drainage, in the management of paediatric acute skin and soft tissue infection (SSTI) appears to reduce Staphylococcus aureus colonization and the likelihood of infection recurrence, a prospective study has found.
12 Oct 2017
Retreatment with ledipasvir and sofosbuvir with add-on ribavirin appears to be effective and well tolerated in genotype 1 hepatitis C virus (HCV)-infected patients who have failed to respond to daclatasvir/asunaprevir combination therapy, according to a study.
16 Oct 2017
Excessive intake of the mineral manganese can be toxic to the heart, according to a new study.