New Drug Approvals
New drug approvals - May 2023
Audiences
Healthcare professional
Industry member
Product type
Therapeutic Products
31 May 2023
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Please click here for a list of summary reports of benefit-risk assessments.
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Product Name | ELELYSO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 200 UNITS/ VIAL |
|---|---|
Active Ingredient | Taliglucerase alfa |
Application type | NDA-1: New biological entity |
Product Registrant | PFIZER PRIVATE LIMITED |
Date of Approval | 03/05/2023 |
Registration No. | SIN16770P |
Indications: Taliglucerase alfa for infusion is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease associated with at least one of the following: splenomegaly, hepatomegaly, anemia, thrombocytopenia. | |
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Product Name | ZEPOSIA CAPSULE 0.92MG ZEPOSIA CAPSULES TREATMENT INITIATION PACK |
|---|---|
Active Ingredient | Ozanimod Hydrochloride |
Application type | NDA-1: New chemical entity NDA-2: New strength |
Product Registrant | BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD |
Date of Approval | 17 May 2023 |
Registration No. | SIN16785P, SIN16786P |
Indications: Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease evidenced by relapses or imaging features, to decrease the frequency of clinical exacerbations (see section 5.1). | |
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Product Name | BERIPLAST P COMBI-SET POWDERS AND SOLVENTS FOR SEALANT 1.0ML, 3.0ML |
|---|---|
Active Ingredient | 1.0ml Vial 1: Factor XIII 60IU/mL Vial 1: Fibrinogen: 90mg/mL Vial 2: Aprotinin solution 1000KIU/mL Vial 3: Thrombin 500IU/mL Vial 4: Calcium chloride dihydrate 5.9mg/mL 3.0ml Vial 1: Factor XIII 180IU/mL Vial 1: Fibrinogen: 270mg/mL Vial 2: Aprotinin solution 3000KIU/mL Vial 3: Thrombin 1500IU/mL Vial 4: Calcium chloride dihydrate 17.7mg/mL |
Application type | NDA-2/3: New product containing a currently registered entity, new strength |
Product Registrant | CSL BEHRING PTE. LTD. |
Date of Approval | 10/05/2023 |
Registration No. | SIN16775P, SIN16776P |
Indications: Supportive treatment in adults where standard surgical techniques are insufficient • for improvement of haemostasis (including endoscopic treatment of bleeding gastroduodenal ulcer) • as suture support for haemostasis in vascular surgery | |