New drug approvals - September 2023

Product Name

COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 15/15 MICROGRAMS/DOSE (MULTI-DOSE VIAL)

COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 15/15 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)

Active Ingredient

Tozinameran / Famtozinameran

Application type

NDA-1: New biological entity

NDA-2: New dosage form

Product Registrant

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

Date of Approval

07/09/2023

Registration No.

SIN16855P, SIN16856P

Indications:

COMIRNATY (Bivalent) (For 12 Years of Age and Older) (Vials with Grey Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

Product Name

ANDROGEL GEL 16.2MG/G

Active Ingredient

Testosterone

Application type

NDA-2: New formulation, strength

Product Registrant

PHARMED IMPORT & EXPORT PTE LTD

Date of Approval

07/09/2023

Registration No.

SIN16857P

Indications:

ANDROGEL 16.2 mg/g gel is indicated in adults as replacement therapy for male hypogonadism when testosterone deficiency has been clinically and biologically confirmed.

Product Name

BONJESTA EXTENDED-RELEASE TABLETS 20MG/20MG

Active Ingredient

Doxylamine Succinate, Pyridoxine Hydrochloride

Application type

NDA-2: New formulation, dosing regimen

Product Registrant

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Date of Approval

18/09/2023

Registration No.

SIN16865P

Indications:

BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Limitations of Use

BONJESTA has not been studied in women with hyperemesis gravidarum.

Product Name

KIRSTY™ SOLUTION FOR INJECTION IN VIAL 100 UNITS/ML

KIRSTY™ SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 UNITS/ML

Active Ingredient

Insulin aspart (rDNA origin)

Application type

NDA-2: Biosimilar

Product Registrant

MYLAN PHARMACEUTICALS PTE. LTD.

Date of Approval

20/09/2023

Registration No.

SIN16867P, SIN16868P

Indications:

Kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.

Product Name

SKYRIZI CONCENTRATE FOR SOLUTION FOR INFUSION 600MG/10ML

SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE WITH ON-BODY INJECTOR 360MG/2.4ML

Active Ingredient

Risankizumab

Application type

NDA-2: New presentation, strength, indication, dosing regimen

Product Registrant

ABBVIE PTE. LTD.

Date of Approval

27/09/2023

Registration No.

SIN16869P, SIN16870P

Indications:

SKYRIZI is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Product Name

OCREVUS CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/10ML

Active Ingredient

Ocrelizumab

Application type

NDA-1: New chemical entity

Product Registrant

ROCHE SINGAPORE PTE LTD

Date of Approval

28/09/2023

Registration No.

SIN16871P

Indications:

Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features, to reduce the frequency of clinical relapses and delay the progression of physical disability.

Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) with imaging features characteristic of inflammatory activity to delay progression of physical disability.

Product Name

CALQUENCE FILM-COATED TABLET 100MG

Active Ingredient

Acalabrutinib

Application type

NDA-2: New dosage form

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

29/09/2023

Registration No.

SIN16875P

Indications:

CALQUENCE is indicated:

· in combination with obinutuzumab or as monotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

· as monotherapy for the treatment of patients with CLL/SLL who have received at least one prior therapy.

· for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.