New drug approvals - April 2023

Product Name

GAVRETO HARD CAPSULE 100MG

Active Ingredient

Pralsetinib

Application type

NDA-1

Product Registrant

ROCHE SINGAPORE PTE LTD

Date of Approval

06 April 2023

Registration No.

SIN16755P

Indications:

Non-Small Cell Lung Cancer (NSCLC)

Gavreto is indicated for the treatment of adult patients with rearranged during transfection (RET) fusion-positive, locally advanced or metastatic NSCLC.

RET-Mutant Medullary Thyroid Cancer (MTC)

Gavreto is indicated for the treatment of adult patients with locally advanced or metastatic RET-mutant MTC who require systemic therapy.

Product Name

ALBUMIN SG INJECTION 20%

Active Ingredient

Human serum albumin

Application type

NDA-2

Product Registrant

THE REG CONSULTANTS PTE LTD

Date of Approval

20 April 2023

Registration No.

SIN16765P

Indications:

Hypoalbuminemia caused by albumin loss (burn, nephrotic syndrome, etc), dysfunction of albumin synthesis (liver cirrhosis, etc) and haemorrhagic shock.

Product Name

IMMUNOGLOBULIN SG INJECTION 50MG/ML

Active Ingredient

Human immunoglobulin G

Application type

NDA-2

Product Registrant

THE REG CONSULTANTS PTE LTD

Date of Approval

20 April 2023

Registration No.

SIN16766P

Indications:

Replacement therapy in adults, children, and adolescents (0–18 years) in:

•Primary immunodefi­ciency syndromes (PID) with impaired antibody production

•Secondary immunode­ficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specifi­c antibody failure (PSAF)* or serum IgG level of 4g/L

* PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines

Immunomodulation in adults, children and adolescents (0–18 years) in:

•Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count

•Guillain Barré syndrome

•Kawasaki disease (in conjunction with acetylsalicylic acid; see “Dosage and Administration”)

Product Name

DEXDOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MICROGRAMS/ML

Active Ingredient

Dexmedetomidine

Application type

NDA-2

Product Registrant

ORION PHARMA (SG) PTE. LTD.

Date of Approval

25 April 2023

Registration No.

SIN16767P

Indications:

For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).

For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.

Product Name

ZINC AGUETTANT CONCENTRATE FOR SOLUTION FOR INJUSION 1MG/ML

Active Ingredient

Zinc gluconate equivalent to elemental zinc

Application type

NDA-2

Product Registrant

AGUETTANT ASIA PACIFIC PTE LTD

Date of Approval

25 April 2023

Registration No.

SIN16768P

Indications:

Zinc supplementation in prolonged parenteral nutrition and in situations where a pronounced zinc deficiency may occur: e.g. severe malnutrition, hypercatabolism, digestive fistula, chronic diarrhoea.

Product Name

QINLOCK TABLET 50 MG

Active Ingredient

Ripretinib

Application type

NDA-1

Product Registrant

SPECIALISED THERAPEUTICS ASIA PTE LTD

Date of Approval

28 April 2023

Registration No.

SIN16769P

Indications:

QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumours (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib, sunitinib, and regorafenib.

*Evaluated as part of Project Orbis