New drug approvals - Aug 2020
Please click here for a list of summary reports of benefit-risk assessments.
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Product Name
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BALVERSA FILM-COATED TABLETS 3MG, 4MG, 5MG
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Active Ingredient
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Erdafitinib
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Application type
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NDA-1/3
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Product Registrant
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JOHNSON & JOHNSON PTE. LTD.
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Date of Approval
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07/08/2020
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Registration No.
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SIN15986P, SIN15987P, SIN15988P
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Indications:
Balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC), whose tumors have susceptible fibroblast growth factor receptor (FGFR) 3 genetic alterations, who have disease progression during or following at least one line of prior chemotherapy including within 12 months of neoadjuvant or adjuvant chemotherapy.
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Product Name
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DOVATO FILM-COATED TABLET 50MG/ 300MG
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Active Ingredient
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Dolutegravir, Lamivudine
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Application type
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NDA-2
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Product Registrant
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GLAXOSMITHKLINE PTE LTD
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Date of Approval
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13/08/2020
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Registration No.
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SIN15989P
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Indications:
DOVATO is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age weighing at least 40 kg, who have no known or suspected resistance to either antiretroviral component.
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Product Name
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VITRAKVI HARD CAPSULE 100MG AND 25MG
VITRAKVI ORAL SOLUTION 20MG/ML
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Active Ingredient
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Larotrectinib
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Application type
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NDA-1/2/3
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Product Registrant
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BAYER (SOUTH EAST ASIA) PTE LTD
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Date of Approval
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17/08/2020
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Registration No.
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SIN15991P, SIN15992P, SIN15993P
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Indications:
Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that:
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have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,
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are metastatic or where surgical resection is likely to result in severe morbidity, and
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have no satisfactory alternative treatments or that have progressed following treatment.
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Product Name
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FIASP FLEXTOUCH 100U/ML
FIASP SOLUTION FOR INJECTION IN VIAL 100U/ML
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Active Ingredient
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Insulin Aspart
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Application type
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NDA-2
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Product Registrant
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NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
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Date of Approval
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17/08/2020
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Registration No.
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SIN15994P, SIN15995P
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Indications:
Treatment of diabetes mellitus in adults.
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Product Name
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LYSAKARE SOLUTION FOR INFUSION 25G / 25G
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Active Ingredient
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L-Arginine Hydrochloride, L-Lysine Hydrochloride
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Application type
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NDA-2: New combination
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Product Registrant
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NOVARTIS (SINGAPORE) PTE LTD
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Date of Approval
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31/08/2020
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Registration No.
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SIN16003P
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Indications:
LysaKare is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.
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Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Approvals