Most Read Articles
30 Sep 2019
Adolescents with primary enuresis nocturna (PEN) are more likely to have social anxiety (SA), a recent study has found.
Stephen Padilla, 18 Sep 2019
Use of complementary and alternative medicine (CAM) is common among patients with prostate cancer and has seen an increase among those who are newly diagnosed with the disease, a study has shown. Multivitamins and omega-3 fatty acids are the most commonly used CAMs from 1996 to 2016, while vitamin D use has increased dramatically from 2006 to 2010.
Audrey Abella, 30 Sep 2019
Cabozantinib was no better than the combination of mitoxantrone and prednisone for pain relief in heavily pretreated men with metastatic castration-resistant prostate cancer (mCRPC) and symptomatic bone metastases, according to the findings of the COMET-2* trial.

Original New Drug Application Approvals by US FDA (16 - 31 July 2019)

31 Jul 2019
New drug applications approved by US FDA as of 16 - 31 July 2019 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.

RECARBRIO
  • Active Ingredient(s): Imipenem; cilastatin; relebactam
  • Strength: 500 mg; 500 mg; 250 mg
  • Dosage Form(s) / Route(s): Injectable; intravenous
  • Company: Merck Sharp Dohme
  • Approval Date: 16 July 2019
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of the following infections caused by susceptible gram-negative bacteria:
    • Complicated urinary tract infections, including pyelonephritis (cUTI)
    • Complicated intra-abdominal infections (cIAI)
  • Approved Label16 July 2019 (PDF)

ZINC SULFATE
  • Active Ingredient(s): Zinc sulfate
  • Strength: 3 mg/mL; 5 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: American Regent Inc.
  • Approval Date: 18 July 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
  • Approved Label18 July 2019 (PDF)

DRIZALMA SPRINKLE
  • Active Ingredient(s): Duloxetine
  • Strength: 20 mg; 30 mg; 40 mg; 60 mg
  • Dosage Form(s) / Route(s): Capsule, delayed release; oral
  • Company: Sun Pharma Global
  • Approval Date: 19 July 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • Major Depressive Disorder (MDD) in adults
    • Generalized Anxiety Disorder (GAD) in adults and pediatric patients ages 7 years to 17 years old
    • Diabetic Peripheral Neuropathic Pain (DPNP) in adults
    • Chronic Muscoskeletal Pain in adults
  • Approved Label19 July 2019 (PDF)

HADLIMA
  • Active Ingredient(s): Adalimumab-bwwd
  • Strength: 40 mg/0.8 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Samsung Bioepis Co., Ltd.
  • Approval Date: 23 July 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for treatment of:
    • Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
    • Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older. 
    • Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
    • Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
    • Adult Crohn's Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's Disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have lost response to or are intolerant to infliximab products. 
    • Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.
    • Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
  • Approved Label23 July 2019 (PDF)

RUXIENCE
  • Active Ingredient(s): Rituximab-pvvr
  • Strength: 100 mg/10 mL (10mg/mL); 500 mg/50 mL (10mg/mL)
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pfizer, Inc.
  • Approval Date: 23 July 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with:
    • Non-Hodgkin's Lymphoma (NHL): Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent; previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; non-progressing (including stable disease), a low-grade, CD20-positive, B-cell NHL as a single agent after first line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; previously untreated diffuse large B-call, CD20-positive NHL in combination with (cyclophosphamide, doxorubixin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.
    • Chronic Lymphocytic Leukemia (CLL): Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
    • Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.
  • Approved Label23 July 2019 (PDF)

BAQSIMI
  • Active Ingredient(s): Glucagon
  • Strength: 3 mg
  • Dosage Form(s) / Route(s): Powder; inhalation
  • Company: Eli Lilly and Co.
  • Approval Date: 24 July 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of severe hypoglycemia in patients with diabetes ages 4 years and above.
  • Approved Label24 July 2019 (PDF)

ANGIOMAX RTU
  • Active Ingredient(s): Bivalirudin
  • Strength: 250 mg/50 mL (5 mg/mL)
  • Dosage Form(s) / Route(s): Solution; intravenous
  • Company: Maia Pharms Inc.
  • Approval Date: 25 July 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s):Indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
  • Approved Label25 July 2019 (PDF)

ACCRUFER
  • Active Ingredient(s): Ferric maltol
  • Strength: 30 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Shield TX (UK) Ltd.
  • Approval Date: 25 July 2019
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated for the treatment of iron deficiency in adults. 
  • Approved Label25 July 2019 (PDF)

NUBEQA
  • Active Ingredient(s): Darolutamide
  • Strength: 300 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Bayer Healthcare Pharmaceuticals, Inc.
  • Approval Date: 30 July 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
  • Approved Label30 July 2019 (PDF)
Editor's Recommendations
Most Read Articles
30 Sep 2019
Adolescents with primary enuresis nocturna (PEN) are more likely to have social anxiety (SA), a recent study has found.
Stephen Padilla, 18 Sep 2019
Use of complementary and alternative medicine (CAM) is common among patients with prostate cancer and has seen an increase among those who are newly diagnosed with the disease, a study has shown. Multivitamins and omega-3 fatty acids are the most commonly used CAMs from 1996 to 2016, while vitamin D use has increased dramatically from 2006 to 2010.
Audrey Abella, 30 Sep 2019
Cabozantinib was no better than the combination of mitoxantrone and prednisone for pain relief in heavily pretreated men with metastatic castration-resistant prostate cancer (mCRPC) and symptomatic bone metastases, according to the findings of the COMET-2* trial.