Most Read Articles
12 Apr 2017
Patients with fibromyalgia syndrome (FMS) are at an increased risk of peptic ulcer disease (PUD), a new study shows.
01 Jun 2015
A mixture of the flavonoids diosmin, troxerutin, and hesperidin is safe and effective for the symptomatic management of patients with acute haemorrhoidal disease, a prospective, randomised, triple-blind, controlled trial revealed.

Original New Drug Application Approvals by US FDA (16- 31 August 2017)

31 Aug 2017
New drug applications approved by US FDA as of 16 - 31 August 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.

LYNPARZA
  • Active Ingredient(s): OLAPARIB
  • Strength: 100MG; 150MG
  • Dosage Form: Oral tablet
  • Company: Astrazeneca Pharms
  • Approval Date: August 17, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for:
    • for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
    • or the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza
  • Approved Label: 08/17/2017 (PDF)

DRAX EXAMETAZIME
  • Active Ingredient(s): DRAX EXAMETAZIM
  • Strength: 0.5MG/VIAL [0.37 GBQ UP TO 2.00 GBQ (10MCI UP TO 54MCI)
  • Dosage Form: Kit; Preparation for Intravenous Use
  • Company: Jubilant Draximage
  • Approval Date: August 17, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease
  • Approved Label: 08/17/2017 (PDF)

BESPONSA
  • Active Ingredient(s): INOTUZUMAB OZOGAMICIN
  • Strength: 1MG/VIAL
  • Dosage Form: Lyophilized powder for injection solution
  • Company: Wyeth Pharms Inc
  • Approval Date: August 17, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
  • Approved Label: 08/17/2017 (PDF)

DUZALLO
  • Active Ingredient(s): LESINURAD;ALLOPURINOL
  • Strength: 200;300 |  200;200
  • Dosage Form: Oral chewable tablet
  • Company: Ardea Biosciences Inc
  • Approval Date: August 18, 2017
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone
  • Approved Label: 08/18/2017 (PDF)

DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
  • Active Ingredient(s): DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
  • Strength: 50MG;300MG;300MG
  • Dosage Form: Oral tablet
  • Company: Aurobindo Pharma Ltd
  • Approval Date: August 18, 2017
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for the treatment of HIV-1 infection alone as a complete regimen in adults and pediatric patients weighing 40 kg and greater
  • Approved Label: Not available

GOCOVRI
  • Active Ingredient(s): AMANTADINE
  • Strength: 68.5MG | 137MG
  • Dosage Form: Oral extended release capsule
  • Company: Asamas Pharma LLC
  • Approval Date: August 24, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
  • Approved Label: 08/24/2017 (PDF)

CYLTEZO
  • Active Ingredient(s): ADALIMUMAB-ADBM
  • Strength: 40MG/0.8ML
  • Dosage Form: Injectable; Injection
  • Company: Boehringer Ingelheim
  • Approval Date: August 25, 2017
  • 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 also lost response to or are intolerant to infliximab
    • Ulcerative Colitis (UC): In ducing 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 CYLTEZO 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: 08/25/2017 (PDF)

BENZNIDAZOLE
  • Active Ingredient(s): BENZNIDAZOLE
  • Strength:12.5MG | 100MG
  • Dosage Form: Oral tablet
  • Company: Chemo Research SL
  • Approval Date: August 29, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi
  • Approved Label: 08/29/2017 (PDF)

VABOMERE
  • Active Ingredient(s): MEROPENEM; VABORBACTAM
  • Strength: 1G;1G/VIAL
  • Dosage Form: Injectable; Injection
  • Company: Rempex Pharms Inc
  • Approval Date: August 29, 2017
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria
  • Approved Label: 08/29/2017 (PDF)

AUSTEDO
  • Active Ingredient(s): DEUTETRABENAZINE
  • Strength: 6MG | 9MG | 12MG
  • Dosage Form: Oral tablet
  • Company: Teva Branded Pharm
  • Approval Date: August 30, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of:
    • Chorea associated with Huntington’s disease
    • Tardive dyskinesia in adults
  • Approved Label: 08/30/2017 (PDF)

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Most Read Articles
12 Apr 2017
Patients with fibromyalgia syndrome (FMS) are at an increased risk of peptic ulcer disease (PUD), a new study shows.
01 Jun 2015
A mixture of the flavonoids diosmin, troxerutin, and hesperidin is safe and effective for the symptomatic management of patients with acute haemorrhoidal disease, a prospective, randomised, triple-blind, controlled trial revealed.