New drug approvals - September 2021

Product Name

PROVEBLUE SOLUTION FOR INJECTION 5MG/ML

Active Ingredient

Methylthioninium chloride trihydrate (methylene blue)

Application type

NDA-1: New chemical/biological entity

Product Registrant

PHARM-D SINGAPORE PRIVATE LIMITED

Date of Approval

03/09/2021

Registration No.

SIN16319P

Indications:

Proveblue® is indicated:

• for the treatment of drug and chemical products-induced methaemoglobinaemia

• as a dye in diagnostic procedures such as fistula detection

• for the delineation of certain body tissues during surgery.

Product Name

DAYVIGO FILM-COATED TABLET 5MG AND 10MG

Active Ingredient

Lemborexant

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

Eisai (Singapore) Pte Ltd

Date of Approval

15/09/2021

Registration No.

SIN16320P, SIN16321P

Indications:

DAYVIGO is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Product Name

Ibrance Film Coated Tablet 75 mg, 100 mg, 125 mg

Active Ingredient

Palbociclib

Application type

NDA-2: New dosage form

Product Registrant

Pfizer Private Limited

Date of Approval

15/09/2021

Registration No.

SIN16322P, SIN16323P, SIN16324P

Indications:

Ibrance is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

- an aromatase inhibitor as initial endocrine-based therapy; or

- fulvestrant in patients with disease progression following endocrine therapy.

Product Name

VYEPTI CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ML

Active Ingredient

Eptinezumab

Application type

NDA-1: New biological entity

Product Registrant

LUNDBECK SINGAPORE PTE LTD

Date of Approval

16 /09/2021

Registration No.

SIN16325P

Indications:

VYEPTI is indicated for prophylaxis of migraine in adults.

Product Name

TAKIPRIL SOLUTION FOR INJECTION 20MG/ML

Active Ingredient

Prilocaine hydrochloride

Application type

NDA-2: New strength / combination

Product Registrant

B. BRAUN SINGAPORE PTE LTD

Date of Approval

17/09/2021

Registration No.

SIN16326P

Indications:

Takipril is indicated in adults for spinal anaesthesia in short-term surgical procedures (see section 4.2).

Product Name

ZEPZELCA POWDER FOR SOLUTION FOR INFUSION 4MG/VIAL

Active Ingredient

Lurbinectedin

Application type

NDA-1: New chemical entity

Product Registrant

Specialised Therapeutics Asia Pte Ltd

Date of Approval

21/09/2021

Registration No.

SIN16327P

Indications:

ZEPZELCA is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have progressed after prior platinum-containing therapy.

This indication is approved under provisional approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see 5.1 Clinical Trials].

*Evaluated as part of Project Orbis

Product Name

INHIXA SOLUTION FOR INJECTION 8000 ANTI-Xa IU (80MG)/0.8ML

Active Ingredient

Enoxaparin Sodium

Application type

NDA-2: New dosage form

Product Registrant

HC HEALTHCARE PTE. LTD.

Date of Approval

22/09/2021

Registration No.

SIN16331P

Indications:

Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in the veins), in particular those which may be associated with orthopedic or general surgery.

Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illnesses.

Treatment of established deep vein thrombosis.

Prevention of thrombus formation in extracorporeal circulation during haemodialysis.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.

Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), in combination with a thrombolytic agent, in patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

Product Name

YUPELRI INHALATION SOLUTION 175MCG/3ML

Active Ingredient

Revefenacin

Application type

NDA-1: New chemical entity

Product Registrant

MYLAN PHARMACEUTICALS PTE. LTD.

Date of Approval

28/09/2021

Registration No.

SIN16336P

Indications:

YUPELRI inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Product Name

COSENTYX POWDER FOR SOLUTION FOR INJECTION IN PREFILLED SYRINGE 75MG/0.5ML

Active Ingredient

Secukinumab

Application type

NDA-3: New strength

Product Registrant

Novartis (Singapore) Pte Ltd

Date of Approval

1 Sep 21

Registration No.

SIN16315P

Indications:

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy (See section CLINICAL STUDIES)