New drug approvals - May 2023

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.

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).

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