Product Name

NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 25MG/0.5ML

NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50MG/ML

NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED PEN 50MG/ML

Active Ingredient

Etanercept

Application type

NDA-2: Biosimilar

NDA-3: Subsequent strength

Product Registrant

MYLAN PHARMACEUTICALS PTE. LTD.

Date of Approval

04/07/2022

Registration No.

SIN16531P

SIN16532P

SIN16533P

Indications:

Adults with Rheumatoid arthritis

Treatment of signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis. Etanercept can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

Paediatric Patients with Juvenile Idiopathic arthritis

Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.

Adults with Psoriatic Arthritis

Etanecept is indicated for reducing signs and symptoms of active arthritis in adult patients with psoriatic arthritis. Etanecept can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

Axial Spondyloarthritis

Adults with Ankylosing Spondylitis (AS)

Treatment of signs and symptoms of active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.

Adults with Non-radiographic Axial spondyloarthritis

Etanercept is indicated for the treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated CRP and/or MRI evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs).

Adults with Plaque Psoriasis

Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or PUVA.

Pediatric Patients with Plaque Psoriasis

Etanercept is indicated for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to other systemic therapies or phototherapies.

Product Name

FORTACIN CUTANEOUS SPRAY SOLUTION 7.5MG/DOSE + 2.5MG/DOSE

Active Ingredient

Lidocaine/Prilocaine

Application type

NDA-2: New dosage form/indication

Product Registrant

Orient Europharma

Date of Approval

5/7/2022

Registration No.

SIN16538P

Indications:

Fortacin is indicated for the treatment of primary premature ejaculation in adult men.

Product Name

VOCABRIA FILM-COATED TABLETS 30MG

VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML

VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 400 MG/ 2 ML

Active Ingredient

Cabotegravir

Application type

NDA-1: New chemical entity

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

5/7/2022

Registration No.

SIN16541P, SIN16542P, SIN16543P

Indications:

Film-coated Tablets:

VOCABRIA tablets are indicated in combination with rilpivirine tablets for short term (see Dosage and Administration) treatment of human immunodeficiency virus (HIV)-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class:

• oral lead-in to assess tolerability of cabotegravir prior to administration of long acting (LA) VOCABRIA injection.

• oral therapy for adults who will miss planned dosing with VOCABRIA injection.

Suspension for Injection:

VOCABRIA injection is indicated in combination with rilpivirine injection for treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class (see Clinical studies).

Product Name

SCEMBLIX FILM-COATED TABLET 20 MG, SCEMBLIX FILM-COATED TABLET 40 MG

Active Ingredient

Asciminib hydrochloride

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

05/07/2022

Registration No.

SIN16539P, SIN16540P

Indications:

Scemblix is indicated for the treatment of adult patients with:

• Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 12 Clinical studies).

*Evaluated via Access

Product Name

SALONPAS DICLOFENAC PATCH 15MG

Active Ingredient

Diclofenac Sodium

Application type

NDA-2: New dosage form

Product Registrant

Hisamitsu Pharmaceutical Co., Inc. Singapore Branch

Date of Approval

07/070/2022

Registration No.

SIN16546P

Indications:

For relief of aches, pains and inflammation associated with :

• muscle pain,

• stiff shoulder

• backache,

• bruises,

• sprains,

• strains,

• joint pain

• tendons inflammation

• elbow pain.

Product Name

RYBREVANT CONCENTRATE FOR SOLUTION FOR INFUSION 350MG/7ML

Active Ingredient

Amivantamab 50mg/ml

Application type

NDA-1: New biological entity

Product Registrant

JOHNSON & JOHNSON PTE. LTD.

Date of Approval

13/07/2022

Registration No.

SIN16548P

Indications:

RYBREVANT™ is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

*Evaluated as part of Project Orbis

Product Name

TEPADINA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL

TEPADINA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 15 MG/VIAL

Active Ingredient

Thiotepa

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

AXXESSBIO PTE LID

Date of Approval

18/7/2022

Registration No.

SIN16552P

SIN16553P

Indications:

TEPADINA is indicated, in combination with other chemotherapy medicinal products:

· with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;

· when high dose chemotherapy with HPCT support is appropriate for the treatment of breast cancer in adult patients and CNS tumours in paediatric patients.

Product Name

ROZEVON FILM-COATED TABLET 40MG/10MG

ROZEVON FILM-COATED TABLET 20MG/10MG

ROZEVON FILM-COATED TABLET 10MG/10MG

ROZEVON FILM-COATED TABLET 5MG/10MG

Active Ingredient

Active ingredient

Application type

NDA-2: New combination

Product Registrant

NOVEM PHARMA PRIVATE LIMITED

Date of Approval

04/07/2022

Registration No.

SIN16534P

SIN16535P

SIN16536P

SIN16537P

Indications:

ROZEVON is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products.

Product Name

PRIMOVIST SOLUTION FOR INJECTION IN VIAL 0.25 mmol/ml

Active Ingredient

Gadoxetate, disodium

Application type

NDA-2: New presentation

Product Registrant

BAYER (SOUTH EAST ASIA) PTE LTD

Date of Approval

21/07/2022

Registration No.

SIN16559P

Indications:

Primovist is indicated for use in adults for the enhancement of magnetic resonance imaging (MRI) of focal liver lesions.