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Original New Drug Application Approvals by US FDA (1 - 15 February 2018)

16 Feb 2018

New drug applications approved by US FDA as of 1 - 15 February 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.

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL

  • Active Ingredient(s): Efavirenz; Lamivudine; Tenofovir Disoproxil
  • Strength: 400 mg; 300 mg; 245 mg
  • Dosage Form: Tablet; Oral
  • Company: Mylan Pharms Inc
  • Approval Date: February 5, 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg
  • Approved Label: 02/05/2018 (PDF)

BIKTARVY
  • Active Ingredient(s): Bictegravir; Emtricitabine; Tenofovir Alafenamide
  • Strength: 50 mg; 200 mg; 25 mg
  • Dosage Form: Tablet; Oral
  • Company: Gilead Sciences Inc
  • Approval Date:February 7, 2018
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY
  • Approved Label: 02/07/2018 (PDF)

RADIOGENIX SYSTEM
  • Active Ingredient(s): Sodium Pertechnetate
  • Strength: 6 Cl
  • Dosage Form: Injectable; Injection
  • Company: Northstar Medical Radioisotopes LLC
  • Approval Date: February 8, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as a radioactive diagnostic agent and can be used in the preparation of FDA approved diagnostic radiopharmaceuticals.  Also indicated in adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy) and in adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
  • Approved Label02/08/2018 (PDF)

DEXYCU
  • Active Ingredient(s): Dexamethasone
  • Strength: 9%
  • Dosage Form: Suspension; Intraocular
  • Company: Icon Bioscience Inc
  • Approval Date: February 9, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of postoperative inflammation
  • Approved Label02/09/2018 (PDF)

SYMDEKO
  • Active Ingredient(s): Tezacaftor; Ivacaftor
  • Strength: 100; 150 mg
  • Dosage Form: Tablet; Oral
  • Company: Vertex Pharms
  • Approval Date: February 12, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence
  • Approved Label02/12/2018 (PDF)

ERLEADA
  • Active Ingredient(s): Apalutamide
  • Strength: 60 mg
  • Dosage Form: Tablet; Oral
  • Company: Janssen Biotech
  • Approval Date: February 14, 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer
  • Approved Label: 02/14/2018 (PDF)
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Most Read Articles
19 Jun 2019
The choice between nonvitamin K antagonist oral anticoagulants (NOACs) or vitamin K antagonists (VKAs) for stroke prevention appears to be complex and largely heterogenous across different, countries, a new study has found.
2 days ago
Monotherapy with tenofovir disoproxil fumarate increases virologic response for up to 240 weeks in pretreated patients with hepatitis B virus infection (HBV) who are resistant to entecavir and/or adefovir, a new study has found.
Elvira Manzano, 3 days ago
Long-term treatment with the interleukin-5 receptor alpha-directed cytolytic monoclonal antibody benralizumab led to long-term control of asthma, improvement in pulmonary function, and was safe in patients with severe eosinophilic asthma in the 2-year integrated analysis of the SIROCCO, CALIMA, and ZONDA pivotal studies plus the BORA extension study reported at ATS 2019.
Pearl Toh, 3 days ago
Emerging evidence is showing that the two major new classes of antidiabetic drugs — SGLT2* inhibitors and GLP-1** receptor agonists (RAs) — not only confer cardiovascular (CV) benefits to patients with type 2 diabetes (T2D), they also delay the loss of kidney function among these patients, potentially providing nephrologists with an additional tool in their armamentarium for managing patients with chronic kidney disease (CKD) in the future.