New drug approvals - Sep 2020
Please click here for a list of summary reports of benefit-risk assessments.
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Product Name
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POLIVY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 140MG
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Active Ingredient
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Polatuzumab vedotin
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Application type
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NDA-1: New biological entity
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Product Registrant
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ROCHE SINGAPORE PTE LTD
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Date of Approval
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08/09/2020
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Registration No.
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SIN16007P
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Indications:
Polivy in combination with bendamustine and MabThera is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma who are not eligible for haematopoietic cell transplant.
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Product Name
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SEMGLEE SOLUTION FOR INJECTION IN A PREFILLED PEN 100U/ML
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Active Ingredient
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Insulin glargine
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Application type
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NDA-2: Biosimilar
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Product Registrant
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MYLAN PHARMACEUTICALS PTE. LTD.
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Date of Approval
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14/09/2020
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Registration No.
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SIN16009P
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Indications:
For the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required.
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Product Name
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FULPHILA SOLUTION FOR INJECTION 6MG/0.6ML
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Active Ingredient
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Pegfilgrastim
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Application type
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NDA-2: Biosimilar
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Product Registrant
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MYLAN PHARMACEUTICALS PTE. LTD.
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Date of Approval
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21/09/2020
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Registration No.
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SIN16012P
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Indications:
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
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Product Name
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ODEFSEY FILM COATED TABLET 200MG/25MG/25MG
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Active Ingredient
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Emtricitabine / Rilpivirine hydrochloride / Tenofovir alafenamide fumarate
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Application type
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NDA-2: New combination
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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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24/09/2020
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Registration No.
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SIN16015P
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Indications:
ODEFSEY® is indicated as a complete regimen for the treatment of human immunodeficiency virus type-1 (HIV-1) infection in adults and pediatric patients (12 years of age and older with body weight at least 35 kg) with a viral load ≤ 100,000 HIV-1 RNA copies/mL at the start of therapy, and without known mutations associated with resistance to any of the three antiretroviral components. (see Pharmacological Properties - Clinical Studies).
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Product Name
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LONQUEX PRE-FILLED SYRINGE 6MG/0.6ML
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Active Ingredient
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Lipegfilgrastim
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Application type
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NDA-1
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Product Registrant
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Drug Houses of Australia Pte Ltd
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Date of Approval
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25/09/2020
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Registration No.
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SIN16019P
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Indications:
Lonquex is indicated in adults for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
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Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Approvals