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New drug approvals - October 2021

Please click here for a list of summary reports of benefit-risk assessments.

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]. *Evaluated via Access

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. *Evaluated as part of Project Orbis

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. *Evaluated as part of Project Orbis

Healthcare professional, Industry member, Therapeutic Products

Published: 22 Oct 2021

New Drug Approvals