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

15 Nov 2017
New drug applications approved by US FDA as of 1 - 15 November 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.

Vyzulta (latanoprostene bunod ophthalmic solution), 0.024%
  • Active Ingredient(s): Latanoprostene bunod
  • Strength: 0.024
  • Dosage Form: Ophthalmic solution
  • Company: Bausch and Lomb Inc
  • Approval Date: November 02, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
  • Approved Label: 11/02/2017 (PDF)

BORTEZOMIB
  • Active Ingredient(s): Bortezomib
  • Strength: 3.5 mg
  • Dosage Form: Injectable;injection
  • Company: Fresenius Kabi USA
  • Approval Date: November 06, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for
    • treatment of patients with multiple myeloma
    • treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy
  • Approved Label: 11/06/2017 (PDF)

PREVYMIS
  • Active Ingredient(s): Letermovir
  • Strength: 240 mg, 480 mg
  • Dosage Form: Tablet;oral
  • Company: Merck Sharp Dohme
  • Approval Date: November 08, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)
  • Approved Label: 11/08/2017 (PDF)

PREVYMIS
  • Active Ingredient(s): Letermovir
  • Strength: 240 mg/12ml, 480 mg/24ml
  • Dosage Form: Injectable;injection
  • Company: Merck Sharp Dohme
  • Approval Date: November 08, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)
  • Approved Label: 11/08/2017 (PDF)

Cinvanti (aprepitant) injectable emulsion
  • Active Ingredient(s): Aprepitant
  • Strength: 130mg
  • Dosage Form: Injectable;injection
  • Company:  Heron Theraps Inc
  • Approval Date: November 09, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in adults, in combination with other antiemetic agents, for the prevention of:
    • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin
    • nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)
  • Approved Label: 11/09/2017 (PDF) 

ABILIFY MYCITE
  • Active Ingredient(s): Aripiprazole
  • Strength: 2 mg |  5 mg | 10 mg | 15 mg | 20 mg | 30mg
  • Dosage Form: Oral with sensor tablet
  • Company: Otsuka Pharm Co Ltd
  • Approval Date: November 13, 2017
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for
    • Treatment of adults with schizophrenia
    • Treatment of bipolar I disorder
      • Acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate
      • Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate
    • Adjunctive treatment of adults with major depressive disorder (MDD)
  • Approved Label: 11/13/2017 (PDF)

TEKTURNA
  • Active Ingredient(s): Aliskiren
  • Strength: 37.5 mg
  • Dosage Form: Oral pellets
  • Company: Noden Pharma
  • Approval Date: November 14, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure
  • Approved Label: 11/14/2017 (PDF)

FASENRA
  • Active Ingredient(s): Benralizumab
  • Strength: 30 mg/mL
  • Dosage Form: Injectable;injection
  • Company: Astrazeneca AB
  • Approval Date: November 14, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
  • Approved Label: 11/14/2017 (PDF)

MEPSEVII
  • Active Ingredient(s): Vestronidase alfa-VJBK
  • Strength: 10 mg / 5 ml
  • Dosage Form: Injectable;injection
  • Company: Ultragenyx Pharm Inc
  • Approval Date: November 15, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for pediatric and adult patients for the treatment of Mucopolysaccharidosis type VII (MPS VII, Sly syndrome)
  • Approved Label: Not available
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Most Read Articles
2 days ago
Use of potassium citrate and thiazides appears to improve health-related quality of life (HRQOL) among stone formers across all Wisconsin Stone Quality of Life (WISQOL) domains without increasing the likelihood of gastrointestinal complaints and fatigue or sexual complaints, respectively, reports a study.
Pearl Toh, 6 days ago
First-line therapy with the BTK* inhibitor ibrutinib plus the anti-CD20 immunotherapy rituximab confers significant survival advantage over the current gold-standard regimen of fludarabine, cyclophosphamide, and rituximab (FCR) for young, fit patients with treatment-naïve chronic lymphocytic leukaemia (CLL), according to the E1912 trial, a large cooperative group study supported by the US National Cancer Institute.
3 days ago
Eating high amounts of red and processed meat prior to a diagnosis of colorectal cancer appears to be associated with shorter survival time, although a possible weak association cannot be excluded, a study has shown.
3 days ago
Middle-aged Caucasian men who are dissatisfied with their marriage are at higher risk of sudden cardiac death regardless of other cardiovascular risk factors, a new study reports.