print small large

This application is a service of the Singapore Government.

Health Sciences Authority

December 2016

This report lists applications approved during the period as indicated above.  It includes first new drug application of an innovator product and first combination, dosage form or new usage of an innovator product.  The list also includes new indication approved for an existing medicinal product.

NEW DRUG APPROVALS

PRODUCT NAME

 

NEW INDICATION APPROVALS

PRODUCT NAME

 

NEW DRUG APPROVALS

Product Name

ESBRIET HARD CAPSULE 267 MG

Active Ingredient

Pirfenidone 

Application type

NDA-1: New chemical entity

Licence Holder

ROCHE SINGAPORE PTE. LTD.  

Date of Approval

1 Dec 2016

Licence No.

SIN15124P

Indications:

ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Product Name

PENTASA RECTAL SUSPENSION 1 G

Active Ingredient

Mesalazine

Application type

NDA-2: New dosage form

Licence Holder

FERRING PHARMACEUTICALS PTE. LTD.

Date of Approval

14 Dec 2016

Licence No.

SIN15137P

Indications:

Treatment of ulcerative proctosigmoiditis.

Product Name

TOUJEO SOLOSTAR 300 UNITS/ ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Active Ingredient

Insulin Glargine

Application type

NDA-2: New strength

Licence Holder

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

14 Dec 2016

Licence No.

SIN15138P

Indications:

Treatment of diabetes mellitus in adults.

Product Name

TAGRISSO TABLET 40 MG AND 80 MG

Active Ingredient

Osimertinib

Application type

NDA-1: New chemical entity and NDA-3: New strength

Licence Holder

ASTRAZENECA SINGAPORE PTE. LTD.  

Date of Approval

15 Dec 2016

Licence No.

SIN15139P and SIN15140P

Indications:

TAGRISSO (osimertinib) is indicated for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) who have progressed on or after EGFR TKI therapy. (See Clinical efficacy and safety section)

Product Name

GARDASIL 9 SUSPENSION FOR INJECTION

Active Ingredient

Human Papillomavirus Type 11 L1 Protein

Human Papillomavirus Type 16 L1 Protein

Human Papillomavirus Type 18 L1 Protein

Human Papillomavirus Type 31 L1 Protein

Human Papillomavirus Type 33 L1 Protein

Human Papillomavirus Type 45 L1 Protein

Human Papillomavirus Type 52 L1 Protein

Human Papillomavirus Type 58 L1 Protein

Human Papillomavirus Type 6 L1 Protein

Application type

NDA-1: New biological entity

Licence Holder

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

16 Dec 2016

Licence No.

SIN15141P

Indications:

GARDASIL 9 is a vaccine indicated in girls and women from 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancer; premalignant genital lesions (cervical, vulvar and vaginal); premalignant anal lesions; HPV infections; cervical adenocarcinoma in situ (AIS); and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is indicated in boys and men from 9 through 26 years of age for the prevention of premaglinant lesions and HPV infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 and genital warts (condyloma acuminata) caused by HPV types 6 and 11.

Product Name

FLUIMUCIL GRANULES 600 MG/ SACHET

Active Ingredient

Acetylcysteine

Application type

NDA-2: New dosage form

Licence Holder

UNITED ITALIAN TRADING CORPORATION (PTE) LTD.

Date of Approval

29 Dec 2016

Licence No.

SIN15144P

Indications:

FLUIMUCIL ® A Effervescent Tablet 600mg and Fluimucil® Granules 600mg are indicated as an adjuvant treatment in certain clinical condition characterized by the presence of thick and viscous mucoid or mucopurulent secretions such as:

-      Chronic bronchopulmonary diseases (chronic obstructive pulmonary disease, emphysema with bronchitis, chronic asthmatic bronchitis, bronchiectasis);

-      Acute bronchopulmonary diseases (asthma with bronchial mucus plugging, bronchitis, bronchopneumonia, tracheobronchitis, bronchiolitis, pulmonary complications of cystic fibrosis, pulmonary complications associated with surgery).

 

NEW INDICATION APPROVALS

Product Name

HUMIRA SOLUTION FOR INJECTION 40 MG/ 0.8 ML (SYRINGE AND PEN)

HUMIRA SOLUTION FOR INJECTION 40 MG/ 0.8 ML (VIAL)

Active Ingredient

Adalimumab

Licence Holder

ABBVIE PTE. LTD.

Date of Approval

15 Dec 2016

Indications:

Uveitis

Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Product Name

GAZYVA CONCENTRATE FOR SOLUTION FOR INFUSION 1000 MG/ 40 ML

Active Ingredient

Obinutuzumab

Licence Holder

ROCHE SINGAPORE PTE. LTD.

Date of Approval

22 Dec 2016

Indications:

Follicular Lymphoma

Gazyva in combination with bendamustine, followed by Gazyva maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond to, or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.