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 Label: 16 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 Label: 18 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 Label: 19 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 Label: 23 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 Label: 23 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 Label: 24 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 Label: 25 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 Label: 25 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 Label: 30 July 2019 (PDF)