| 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 entityNDA-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/MLKIRSTY™ 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/10MLSKYRIZI 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. | |
HSA: Health Sciences Authority
Link to the HSA announcement: https://www.hsa.gov.sg/announcements/new-drug-approval/new-drug-approvals—sep-2023
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