New drug approvals - October 2023

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Product Name

GOOFICE FILM-COATED TABLET 5MG

Active Ingredient

Elobixibat

Application type

NDA-1: New chemical entity

Product Registrant

EISAI (SINGAPORE) PTE. LTD.

Date of Approval

02/10/2023

Registration No.

SIN16878P

Indications:

GOOFICE® is indicated for the treatment of chronic idiopathic constipation in adults.

Product Name

PAXLOVID FILM-COATED TABLETS

Active Ingredient

Nirmatrelvir, Ritonavir

Application type

NDA-1: New chemical entity

(Transition from PSAR to marketing authorisation)

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

02/10/2023

Registration No.

SIN16877P

Indications:

PAXLOVID is indicated for the treatment of mild-to-moderate Coronavirus Disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

Product Name

SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5

(50 MICROGRAMS/50 MICROGRAMS)/ML DISPERSION FOR INJECTION

Active Ingredient

Elasomeran, Davesomeran

Application type

NDA-1: New biological entity

Product Registrant

MODERNA BIOTECH SINGAPORE PTE. LTD.

Date of Approval

11/10/2023

Registration No.

SIN16881P

Indications:

Spikevax bivalent Original/Omicron BA.4-5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 (see sections 4.2 and 5.1).

The use of this vaccine should be in accordance with official recommendations.

Product Name

SPEVIGO CONCENTRATE FOR SOLUTION FOR INFUSION 450 MG/7.5 ML

Active Ingredient

Spesolimab

Application type

NDA-1: New biological entity

Product Registrant

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Date of Approval

12/10/2023

Registration No.

SIN16883P

Indications:

SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults.

Product Name

NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5µG/DOSE (RECOMBINANT, ADJUVANTED)

Active Ingredient

SARS-CoV-2 recombinant Spike Protein (rS)

Application type

NDA-1: New biological entity

Product Registrant

PHARMENG TECHNOLOGY PTE LTD

Date of Approval

17/10/2023

Registration No.

SIN16886P

Indications:

Nuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.

Product Name

PERIOLIMEL N4E EMULSION FOR INFUSION

Active Ingredients

(Compartment 1) Alanine 3.66g/L

(Compartment 1) Arginine 2.48g/L

(Compartment 1) Aspartic Acid 0.73g/L

(Compartment 1) Glutamic Acid 1.26g/L

(Compartment 1) Glycine 1.76g/L

(Compartment 1) Histidine 1.51g/L

(Compartment 1) Isoleucine 1.26g/L

(Compartment 1) Leucine 1.76g/L

(Compartment 1) Lysine Acetate eqv Lysine 1.99g/L

(Compartment 1) Magnesium Chloride Hexahydrate 0.45g/L

(Compartment 1) Methionine 1.26g/L

(Compartment 1) Phenylalanine 1.76g/L

(Compartment 1) Potassium Chloride 1.19g/L

(Compartment 1) Proline 1.51g/L

(Compartment 1) Serine 1.00g/L

(Compartment 1) Sodium Acetate Trihydrate 1.16g/L

(Compartment 1) Sodium Glycerophosphate, Hydrated 1.91g/L

(Compartment 1) Threonine 1.26g/L

(Compartment 1) Tryptophan 0.42g/L

(Compartment 1) Tyrosine 0.06g/L

(Compartment 1) Valine 1.62g/L

(Compartment 2) Calcium Chloride Dihydrate 0.30g/L

(Compartment 2) Glucose Monohydrate eqv Glucose Anhydrous 75.0g/L

(Compartment 3) Refined Olive Oil + Soya-bean Oil (80:20) 30g/L

Application type

NDA-2: New combination

Product Registrant

BAXTER HEALTHCARE (ASIA) PTE LTD

Date of Approval

20/10/2023

Registration No.

SIN16888P

Indications:

PeriOLIMEL N4E is indicated for parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Product Name

OLIMEL N7E EMULSION FOR INFUSION

Active Ingredients

(Compartment 1) Alanine 6.41g/L

(Compartment 1) Arginine 4.34g/L

(Compartment 1) Aspartic Acid 1.28g/L

(Compartment 1) Glutamic Acid 2.21g/L

(Compartment 1) Glycine 3.07g/L

(Compartment 1) Histidine 2.64g/L

(Compartment 1) Isoleucine 2.21g/L

(Compartment 1) Leucine 3.07g/L

(Compartment 1) Lysine Acetate eqv Lysine 3.48g/L

(Compartment 1) Magnesium Chloride Hexahydrate 0.81g/L

(Compartment 1) Methionine 2.21g/L

(Compartment 1) Phenylalanine 3.07g/L

(Compartment 1) Potassium Chloride 2.24g/L

(Compartment 1) Proline 2.64g/L

(Compartment 1) Serine 1.75g/L

(Compartment 1) Sodium Acetate Trihydrate 1.50g/L

(Compartment 1) Sodium Glycerophosphate, Hydrated 3.67g/L

(Compartment 1) Threonine 2.21g/L

(Compartment 1) Tryptophan 0.74g/L

(Compartment 1) Tyrosine 0.11g/L

(Compartment 1) Valine 2.83g/L

(Compartment 2) Calcium Chloride Dihydrate 0.52g/L

(Compartment 2) Glucose Monohydrate eqv Glucose Anhydrous 140g/L

(Compartment 3) Refined Olive Oil + Soya-bean Oil (80:20) 40g/L

Application type

NDA-3: Line extension

Product Registrant

BAXTER HEALTHCARE (ASIA) PTE LTD

Date of Approval

20/10/2023

Registration No.

SIN16889P

Indications:

OLIMEL N7E is indicated for parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Product Name

OLIMEL N9E EMULSION FOR INFUSION

Active Ingredients

(Compartment 1) Alanine 8.24g/L

(Compartment 1) Arginine 5.58g/L

(Compartment 1) Aspartic Acid 1.65g/L

(Compartment 1) Glutamic Acid 2.84g/L

(Compartment 1) Glycine 3.95g/L

(Compartment 1) Histidine 3.40g/L

(Compartment 1) Isoleucine 2.84g/L

(Compartment 1) Leucine 3.95g/L

(Compartment 1) Lysine Acetate eqv Lysine 4.48g/L

(Compartment 1) Magnesium Chloride Hexahydrate 0.81g/L

(Compartment 1) Methionine 2.84g/L

(Compartment 1) Phenylalanine 3.95g/L

(Compartment 1) Potassium Chloride 2.24g/L

(Compartment 1) Proline 3.40g/L

(Compartment 1) Serine 2.25g/L

(Compartment 1) Sodium Acetate Trihydrate 1.50g/L

(Compartment 1) Sodium Glycerophosphate, Hydrated 3.67g/L

(Compartment 1) Threonine 2.84g/L

(Compartment 1) Tryptophan 0.95g/L

(Compartment 1) Tyrosine 0.15g/L

(Compartment 1) Valine 3.64g/L

(Compartment 2) Calcium Chloride Dihydrate 0.52g/L

(Compartment 2) Glucose Monohydrate eqv Glucose Anhydrous 110.0g/L

(Compartment 3) Refined Olive Oil + Soya-bean Oil (80:20) 40g/L

Application type

NDA-3: Line extension

Product Registrant

BAXTER HEALTHCARE (ASIA) PTE LTD

Date of Approval

20/10/2023

Registration No.

SIN16890P

Indications:

OLIMEL N9E is indicated for parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Product Name

SKIIP NICOTINE MINI LOZENGE 2MG (MINT)

Active Ingredient

Nicotine Polacrilex

Application type

NDA-2: New salt /dosage form

Product Registrant

RUBICON RESEARCH PRIVATE LIMITED

Date of Approval

30/10/2023

Registration No.

SIN16895P

Indications:

Nicotine Mini Lozenge belongs to a group of medicines which are used to help you stop smoking.

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals