New drug approvals - October 2021

Product Name

SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/ML, 

SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED PEN 150MG/ML

Active Ingredient

Risankizumab

Application type

NDA-2: New dosage form / strength

Product Registrant

ABBVIE PTE. LTD.

Date of Approval

01/10/2021

Registration No.

SIN16338P, SIN16339P

Indications:

SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Product Name

BRUKINSA CAPSULE 80MG

Active Ingredient

Zanubrutinib

Application type

NDA-1: New chemical entity

Product Registrant

BEIGENE SINGAPORE PTE. LTD.

Date of Approval

01/10/2021

Registration No.

SIN16341P

Indications:

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

Product Name

VERQUVO FILM-COATED TABLET 10MG, 5MG, 2.5MG

Active Ingredient

Vericiguat

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

BAYER (SOUTH EAST ASIA) PTE LTD

Date of Approval

01/10/2021

Registration No.

SIN16340P, SIN16342P, SIN16343P

Indications:

VERQUVO (vericiguat) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction, who are stabilised after a recent decompensation event requiring IV therapy. Vericiguat is administered in combination with other HF therapies[see 9. CLINICAL STUDIES].

Product Name

AJOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 225 MG/1.5 ML

Active Ingredient

Fremanezumab

Application type

NDA-2*: New presentation

Product Registrant

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Date of Approval

04/10/2021

Registration No.

SIN16344P

Indications:

AJOVY is indicated for the preventive treatment of migraine in adults.

Product Name

POLIVY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 30 MG

Active Ingredient

Polatuzumab vedotin

Application type

NDA-3: New strength

Product Registrant

ROCHE SINGAPORE PTE. LTD.

Date of Approval

05/10/2021

Registration No.

SIN16345P

Indications:

Polivy in combination with bendamustine and MabThera is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma who are not eligible for haematopoietic cell transplant.

Product Name

LATUDA TABLET 20MG

Active Ingredient

Active ingredient

Application type

NDA-3: New strength

Product Registrant

DKSH SINGAPORE PTE. LTD.

Date of Approval

12/10/2021

Registration No.

SIN16346P

Indications:

LATUDA is indicated for:

• Treatment of adult and adolescent patients age 13 to 17 years with schizophrenia.

• Monotherapy treatment of adult and pediatric patients (13 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression).

• Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).

Product Name

ENSPRYNG SOLUTION FOR INJECTION IN PREFILLED SYRINGE 120MG/1ML

Active Ingredient

Satralizumab

Application type

NDA-1

Product Registrant

ROCHE SINGAPORE PTE. LTD.

Date of Approval

19/10/2021

Registration No.

SIN16348P

Indications:

Enspryng is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescents who are anti-aquaporin 4 (AQP4) seropositive.

Product Name

EVRYSDI POWDER FOR ORAL SOLUTION 0.75MG/ML

Active Ingredient

Risdiplam

Application type

NDA-1: New chemical entity

Product Registrant

ROCHE SINGAPORE PTE. LTD.

Date of Approval

20/10/2021

Registration No.

SIN16349P

Indications:

Evrysdi is indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.

Product Name

TABRECTA FILM-COATED TABLET 150mg,

TABRECTA FILM-COATED TABLET 200mg

Active Ingredient

Capmatinib

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

22/10/2021

Registration No.

SIN16350P, SIN16351P

Indications:

Tabrecta is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation.

Product Name

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

Active Ingredient

Trastuzumab deruxtecan

Application type

NDA-1: New biological entity

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

22/10/2021

Registration No.

SIN16352P

Indications:

ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic

HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

ENHERTU is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received two or more prior regimens, including a trastuzumab-based regimen.