Most Read Articles
Elvira Manzano, 14 Aug 2018
A new study reinforces the gut-brain connection in Alzheimer’s disease (AD), untangling the complex interplay between gut and brain health that could potentially lead to new therapies targeted at manipulating the gut microbiome to treat AD.
Pearl Toh, 09 Jul 2019
A triple-drug combination therapy comprising encorafenib, binimetinib, and cetuximab significantly improved survival compared with the current standard of care chemotherapy in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who had failed one or two prior treatments, according to the BEACON CRC study presented at the recent ESMO World Congress on Gastrointestinal Cancer (ESMO GI).
Roshini Claire Anthony, 4 days ago

Reducing the dose of regorafenib did little to affect the overall tolerability of the drug in patients with metastatic colorectal cancer (mCRC), according to the phase II REARRANGE* trial presented at ESMO GI 2019.

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
Elvira Manzano, 14 Aug 2018
A new study reinforces the gut-brain connection in Alzheimer’s disease (AD), untangling the complex interplay between gut and brain health that could potentially lead to new therapies targeted at manipulating the gut microbiome to treat AD.
Pearl Toh, 09 Jul 2019
A triple-drug combination therapy comprising encorafenib, binimetinib, and cetuximab significantly improved survival compared with the current standard of care chemotherapy in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who had failed one or two prior treatments, according to the BEACON CRC study presented at the recent ESMO World Congress on Gastrointestinal Cancer (ESMO GI).
Roshini Claire Anthony, 4 days ago

Reducing the dose of regorafenib did little to affect the overall tolerability of the drug in patients with metastatic colorectal cancer (mCRC), according to the phase II REARRANGE* trial presented at ESMO GI 2019.