New drug approvals - Apr 2021

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

 

Product Name

VERASEAL SOLUTION FOR SEALANT 80 MG/ML, 500 IU/ML

Active Ingredient

Human Fibrinogen and Human Thrombin

Application type

NDA-2: New dosage form

Product Registrant

GRIFOLS ASIA PACIFIC PTE LTD

Date of Approval

01/04/2021

Registration No.

SIN16143P

Indications:

VeraSeal is indicated as supportive treatment in adults where standard surgical techniques are insufficient:

- for improvement of haemostasis.

- as suture support: in vascular surgery.

 

Product Name

EYBELIS OPHTHALMIC SOLUTION 0.002%

Active Ingredient

Omidenepag Isopropyl

Application type

NDA-1: New chemical entity

Product Registrant

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Date of Approval

07/04/2021

Registration No.

SIN16150P

Indications:

Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension

 

Product Name

ATECTURA BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /320 MCG

ATECTURA BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /160 MCG

ATECTURA BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /80 MCG

Active Ingredient

Indacaterol/Mometasone furoate

Application type

NDA-2/3: New combination/New strength

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

07/04/2021

Registration No.

SIN16147P

SIN16148P

SIN16149P

Indications:

Atectura Breezhaler is indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older where use of a combination of long-acting beta2-agonist and inhaled corticosteroid is appropriate.

 

Product Name

ENERZAIR BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /50 MCG /160 MCG

Active Ingredient

Indacaterol/ Glycopyrronium/ Mometasone furoate

Application type

NDA-2: New combination

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

14/04/2021

Registration No.

SIN16153P

Indications:

Enerzair Breezhaler is indicated as a once-daily maintenance treatment of asthma, and to reduce asthma exacerbations, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid.

 

Product Name

OZEMPIC SOLUTION FOR INJECTION IN PRE-FILLED PEN 1 MG/DOSE, 0.25 MG, 0.5 G/DOSE

Active Ingredient

Semaglutide

Application type

NDA-1: New Biological Entity

Product Registrant

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Date of Approval

21/04/2021

Registration No.

SIN16164P, SIN16165P

Indications:

Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
  • in addition to other medicinal products for the treatment of diabetes.

 

Product Name

CRYSVITA® SOLUTION FOR INJECTION 10MG/ML, 20MG/ML, 30MG/ML

Active Ingredient

Burosumab

Application type

NDA-1/3: New Biological Entity, New Strengths

Product Registrant

KYOWA KIRIN ASIA PACIFIC PTE LTD

Date of Approval

30/04/2021

Registration No.

SIN16176P, SIN16177P, SIN16178P

Indications:

CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older.

 

Product Name

MVASI CONCENTRATE FOR SOLUTION FOR INFUSION 25MG/ML

Active Ingredient

Bevacizumab

Application type

NDA-2: Biosimilar

Product Registrant

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Date of Approval

10/04/2021

Registration No.

SIN16151P

Indications:

Metastatic carcinoma of the colon or rectum(mCRC)

MVASI in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.

Metastatic Breast Cancer (mBC)

MVASI in combination with paclitaxel is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer.

MVASI in combination with capecitabine is indicated for first-line treatment of patients with HER2-negative metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with MVASI in combination with capecitabine.

The effectiveness of MVASI in metastatic breast cancer (mBC) is based on an improvement in progression-free survival. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with MVASI in breast cancer.

Non-Small Cell Lung Cancer (NSCLC)

MVASI, in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.

MVASI, in combination with erlotinib, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.

Malignant Glioma (WHO Grade IV) - Glioblastoma

MVASI, as a single agent is indicated for the treatment of patients with glioblastoma after relapse or disease progression following prior therapy. The effectiveness of MVASI in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease-related symptoms or increased survival with MVASI.

Advanced and/or metastatic Renal Cell Cancer (mRCC)

MVASI in combination with interferon alfa-2a is indicated for first-line treatment of patients with advance and/or metastatic renal cell cancer.

Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

MVASI, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of advanced (FIGO stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.

MVASI, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel is indicated for the treatment of patients with recurrent, platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors.

MVASI in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.

Cervical Cancer

MVASI in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.

 

Product Name

Nucala Solution for Injection in Pre-filled Syringe 100mg/mL

Nucala Solution for Injection in Pre-filled Pen 100mg/mL

Active Ingredient

Mepolizumab

Application type

NDA-2: New presentation

Product Registrant

GlaxoSmithKline Pte Ltd

Date of Approval

27/04/2021

Registration No.

SIN16171P, SIN16172P

Indications:

Severe Eosinophilic Asthma

NUCALA is indicated as add-on maintenance treatment of severe eosinophilic asthma in patients 12 years and older.

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

NUCALA is indicated as add-on treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients.


Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals