Most Read Articles
Rachel Soon, 16 Mar 2018

Intake of calcium supplements may up the risk of developing sessile serrated adenomas or polyps (SSA/Ps) in the colon, according to a new study.

30 Nov 2017
Fluarex Tetra - Inactivated quadrivalent influenza vaccine (split virion) vaccine (inj) 0.5 mL - GlaxoSmithKline
18 Apr 2018
In patients with rheumatoid arthritis (RA), temporary cessation of methotrexate (MTX) treatment for 2 weeks following influenza vaccination appears to improve the immunogenicity of the vaccine without increasing RA disease activity, according to a study.
13 Feb 2018
Short-term treatment with methotrexate at >0.5 defined daily dose (8.75 mg/week) may help reduce the risk of ischaemic stroke in rheumatoid arthritis (RA) patients, while hydroxychloroquine and sulfasalazine have neutral effects, a retrospective study has found.

Original New Drug Application Approvals by US FDA (16 - 28 February 2018)

28 Feb 2018

New drug applications approved by US FDA as of 16 - 28 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.

OSMOLEX ER

  • Active Ingredient(s): Amantadine
  • Strength: 129mg; 193mg; 258mg
  • Dosage Form: Tablet, extended release; Oral
  • Company: Osmotica Pharm US
  • Approval Date: February 16, 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adult patients 
  • Approved Label02/16/2018 (PDF)

IMBRUVICA
  • Active Ingredient(s): Ibrutinib
  • Strength: 140mg; 280mg; 420mg; 560mg
  • Dosage Form: Tablet; Oral
  • Company: Pharmacyclics LLC
  • Approval Date: February 16, 2018
  • Submission Classification: Type 3 - New Dosage Form    
  • Indication(s): Indicated for the treatment of adult patients with: 
    • Mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 
    • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma
    • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
    • Waldenström’s macroglobulinemia (WM)
    • Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 
    • Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy
  • Approved Label02/16/2018 (PDF)

LUSDUNA
  • Active Ingredient(s): Insulin Glargine
  • Strength: 100 units/ml
  • Dosage Form: Injectable; Injection
  • Company: Merck Sharp Dohme
  • Approval Date: February 22, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer    
  • Indication(s): Not available
  • Approved Label: Not available

EFAVIRENZ
  • Active Ingredient(s): Efavirenz
  • Strength: 50mg; 100mg; 200mg
  • Dosage Form: Tablet; Oral
  • Company: Micro Labs Ltd India
  • Approval Date: February 23, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer    
  • Indication(s): Not available
  • Approved Label: Not available

APADAZ
  • Active Ingredient(s): Benzhydrocodone; Acetaminophen
  • Strength: 6.12mg; 325mg
  • Dosage Form: Tablet; Oral
  • Company: Kempharm Inc
  • Approval Date: February 23, 2018
  • Submission Classification: Type 4 - New Combination    
  • Indication(s): Indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
  • Approved Label02/23/2018 (PDF)

SINCALIDE
  • Active Ingredient(s): Sincalide
  • Strength: 5mcg/vial
  • Dosage Form: Injectable; Injection
  • Company: Maia Pharms Inc
  • Approval Date: February 23, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer    
  • Indication(s): Not available
  • Approved Label: Not available

VERZENIO
  • Active Ingredient(s): Abemaciclib
  • Strength: 50mg; 100mg; 150mg; 200mg
  • Dosage Form: Tablet; Oral
  • Company: Eli Lilly and Co.
  • Approval Date: February 26, 2018
  • Submission Classification: Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
  • Indication(s): Indicated:
    • in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
    • in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
    • as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
  • Approved Label02/26/2018 (PDF)
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Most Read Articles
Rachel Soon, 16 Mar 2018

Intake of calcium supplements may up the risk of developing sessile serrated adenomas or polyps (SSA/Ps) in the colon, according to a new study.

30 Nov 2017
Fluarex Tetra - Inactivated quadrivalent influenza vaccine (split virion) vaccine (inj) 0.5 mL - GlaxoSmithKline
18 Apr 2018
In patients with rheumatoid arthritis (RA), temporary cessation of methotrexate (MTX) treatment for 2 weeks following influenza vaccination appears to improve the immunogenicity of the vaccine without increasing RA disease activity, according to a study.
13 Feb 2018
Short-term treatment with methotrexate at >0.5 defined daily dose (8.75 mg/week) may help reduce the risk of ischaemic stroke in rheumatoid arthritis (RA) patients, while hydroxychloroquine and sulfasalazine have neutral effects, a retrospective study has found.