New drug approvals - March 2022

Product Name

XPOVIO FILM-COATED TABLETS 20MG

Active Ingredient

Selinexor

Application type

NDA-1: New chemical/biological entity

Product Registrant

ANTENGENE SINGAPORE PTE LTD

Date of Approval

01/03/2022

Registration No.

SIN16434P

Indications:

1.1 Multiple Myeloma

• XPOVIO in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

• XPOVIO in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody.

1.2 Diffuse Large B‐Cell Lymphoma

XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy who are not eligible for haematopoietic cell transplant [see Clinical Studies (14.2)].

Product Name

VANCOVER CAPSULE 125MG AND 250MG

Active Ingredient

Vancomycin

Application type

NDA-2/3: New formulation and new strength

Product Registrant

ORIENT EUROPHARMA PTE LTD

Date of Approval

11/03/2022

Registration No.

SIN16444P and SIN16445P

Indications:

Vancomycin Hydrochloride Capsule is indicated for the treatment of C. difficile-associated diarrhea. Vancomycin Hydrochloride Capsule is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.

Limitations of Use

Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsule must be given orally for these infections.

Product Name

PRONAXEN ORAL SUSPENSION 25MG/ML

Active Ingredient

Naproxen

Application type

NDA-2: New formulation

Product Registrant

ORION PHARMA (SG) PTE LTD

Date of Approval

23/03/2022

Registration No.

SIN16449P

Indications:

Therapeutic indications

Adults

• Rheumatoid arthritis, spondyloarthropathies (including ankylosing spondylitis)

• Osteoarthrosis

• Acute gout

• Acute musculoskeletal disorders with pain

• Dysmenorrhoea

Children

• Juvenile rheumatoid arthritis

Product Name

RUXIENCE CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ML AND 500MG/50ML

Active Ingredient

Rituximab

Application type

NDA-2: Biosimilar

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

25/03/2022

Registration No.

SIN16451P and SIN16452P

Indications:

Non-Hodgkin’s lymphoma (NHL)

RUXIENCE is indicated for the treatment of:

• patients with CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma (DLCL) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy.

• previously untreated patients with stage III-IV follicular lymphoma in combination with cyclophosphamide, vincristine and prednisolone (CVP) chemotherapy.

patients with relapsed or chemoresistant indolent B-cell non-Hodgkin’s lymphomas.

RUXIENCE maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

Chronic lymphocytic leukaemia (CLL)

RUXIENCE is indicated in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL.

Rheumatoid arthritis

RUXIENCE in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies.

Product Name

MENQUADFI - MENINGOCOCCOL VACCINE, SOLUTION FOR INJECTION IN 0.5 ML VIAL

Active Ingredient

Neisseria meningitidis group A polysaccharide 10 µg

Neisseria meningitidis group C polysaccharide 10 µg

Neisseria meningitidis group Y polysaccharide 10 µg

Neisseria meningitidis group W polysaccharide 10 µg

Conjugated to tetanus toxoid carrier protein 55 µg

Application type

NDA-2: New Dosage

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

29/03/2022

Registration No.

SIN16454P

Indications:

MenQuadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.

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

Product Name

DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 100MG/0.67ML

Active Ingredient

Dupilumab

Application type

NDA-2: New formulation

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

30/03/2022

Registration No.

SIN16458P

Indications:

DUPIXENT is indicated for the following diseases:

1.1 Atopic Dermatitis

DUPIXENT is indicated for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis who require chronic treatment and whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

1.2 Asthma

DUPIXENT is indicated in patients 6 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by elevated blood eosinophils and/or elevated FeNO.

DUPIXENT is indicated as maintenance therapy for oral corticosteroid-dependent asthma

*Evaluated via Access