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New drug approvals - March 2023

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

Product Name

MOUNJARO INJECTION 2.5MG/0/5ML, 5MG/0.5ML, 7.5MG/0.5ML, 10MG/0.5ML, 12.5MG/0.5ML AND 15MG/0.5ML

Active Ingredient

Tirzepatide

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

DKSH SINGAPORE PTE. LTD.

Date of Approval

01/03/2023

Registration No.

SIN16714P, SIN16716P, SIN16717P, SIN16718P, SIN16719P AND SIN16720P

Indications:

MOUNJARO™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use

• MOUNJARO has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)].

• MOUNJARO is not indicated for use in patients with type 1 diabetes mellitus.

*Evaluated via Access

Product Name

BREZTRI AEROSPHERE PRESSURISED INHALATION SUSPENSION 160 MCG/7.2 MCG/5 MCG PER ACTUATION

Active Ingredient

Budesonide, glycopyrronium, formoterol

Application type

NDA-2: New combination

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

01/03/2023

Registration No.

SIN16723P

Indications:

Maintenance treatment to relieve symptoms and prevent exacerbations in adult patients with moderate to very severe chronic obstructive pulmonary disease (COPD) (see Section 5.1).

 

Product Name

LEUPRORELIN SANDOZ IMPLANT IN SYRINGE 3.6 MG, 5 MG

Active Ingredient

Leuprorelin acetate eqv leuprorelin

Application type

NDA-2: New dosage form

NDA-3: New strength

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

21/03/2023

Registration No.

SIN16740P, SIN16739P

Indications:

Palliative treatment of patients with advanced hormone-dependent prostate carcinoma.

 

Product Name

WEGOVY 0.25MG, 0.5MG, 1.0MG, 1.7MG and 2.4MG FLEXTOUCH SOLUTION FOR INJECTION in PRE-FILLED PEN

Active Ingredient

Semaglutide

Application type

NDA-2: New product containing registered entity

NDA-3: New strength

Product Registrant

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Date of Approval

24/03/2023

Registration No.

SIN16744P, SIN16745P, SIN16746P, SIN16747P and SIN16748P

Indications:

Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of

• ≥30 kg/m2 (obesity), or

• ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g.dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

 

Product Name

SPINRAZA SOLUTION FOR INJECTION 12MG/5ML

Active Ingredient

Nusinersen sodium

Application type

NDA-1: New chemical entity

Product Registrant

ZUELLIG PHARMA PTE. LTD.

Date of Approval

31/03/2023

Registration No.

SIN16751P

Indications:

Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.


Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals