Most Read Articles
5 days ago
Girls with eosinophilic oesophagitis (EoE) who show initial response to directed therapy will tend to continue to respond well to treatment, a recent study has shown.
Pearl Toh, 3 days ago
Adding a LAMA* to the double combination therapy of ICS** plus LABA*** in a single inhaler improves lung function and reduces exacerbations in patients whose asthma is inadequately controlled with the combination treatment, according to the TRIMARAN and TRIGGER# studies presented at ERS 2019.
Elvira Manzano, 4 days ago
Final overall survival (OS) results from the double-blind phase III FLAURA study reinforce osimertinib as the standard frontline treatment for epidermal growth factor receptor-mutated (EGFRm) non–small cell lung cancer (NSCLC), say leading oncologists at ESMO 2019.
Tristan Manalac, 3 days ago
Babies born to mothers exposed to high levels of bisphenol A during pregnancy are at a greater risk of wheezing and poor lung function, according to a new study presented at the recently concluded International Congress of the European Respiratory Society (ERS 2019).

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
5 days ago
Girls with eosinophilic oesophagitis (EoE) who show initial response to directed therapy will tend to continue to respond well to treatment, a recent study has shown.
Pearl Toh, 3 days ago
Adding a LAMA* to the double combination therapy of ICS** plus LABA*** in a single inhaler improves lung function and reduces exacerbations in patients whose asthma is inadequately controlled with the combination treatment, according to the TRIMARAN and TRIGGER# studies presented at ERS 2019.
Elvira Manzano, 4 days ago
Final overall survival (OS) results from the double-blind phase III FLAURA study reinforce osimertinib as the standard frontline treatment for epidermal growth factor receptor-mutated (EGFRm) non–small cell lung cancer (NSCLC), say leading oncologists at ESMO 2019.
Tristan Manalac, 3 days ago
Babies born to mothers exposed to high levels of bisphenol A during pregnancy are at a greater risk of wheezing and poor lung function, according to a new study presented at the recently concluded International Congress of the European Respiratory Society (ERS 2019).