New drug approvals - January 2023

Product Name

TROKENDI XR EXTENDED-RELEASE CAPSULE 25MG, 50MG, 100MG, 200MG

Active Ingredient

Topiramate

Application type

NDA-2: New dosage form

NDA-3: New strength

Product Registrant

ORIENT EUROPHARMA PTE LTD

Date of Approval

05/01/2023

Registration No.

SIN16662P, SIN16663P, SIN16664P, SIN16665P

Indications:

1.1 Monotherapy Epilepsy

TROKENDI XR^® is indicated in patients 6 years of age and older as initial monotherapy for partial onset or primary generalized tonic-clonic seizures [see Clinical Studies (14.2)].

1.2 Adjunctive Therapy Epilepsy

TROKENDI XR^® is indicated as adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.3)].

1.3 Migraine

TROKENDI XR^® is indicated for the prophylaxis of migraine headache in adult patients [see Clinical Studies (14.4)].

Product Name

SUVEZEN 10 MG/10 MG FILM-COATED TABLETS

SUVEZEN 20 MG/10 MG FILM-COATED TABLETS

Active Ingredient

Rosuvastatin, Ezetimibe

Application type

NDA-2: New dosage form

NDA-3: New strength

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

05/01/2023

Registration No.

SIN16660P, SIN16661P

Indications:

Primary Hypercholesterolaemia/Homozygous Familial Hypercholesterolaemia (HoFH)

Suvezen is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia.

Product Name

K-CAB FILM-COATED TABLETS 50MG

Active Ingredient

Tegoprazan

Application type

NDA-1: New chemical entity

Product Registrant

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Date of Approval

11/01/2023

Registration No.

SIN16672P

Indications:

K-CAB is indicated for the treatment of Erosive Gastroesophageal Reflux diseases, Non-erosive Gastroesophageal Reflux disease and Gastric Ulcer. K-CAB is also indicated for the eradication of H.pylori when concurrently given with appropriate antibiotic therapy treatment in patients with peptic ulcer and /or chronic atrophic gastritis.

Product Name

ENTYVIO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/VIAL

Active Ingredient

Vedolizumab

Application type

NDA-2: New dosage form /dosing regimen

Product Registrant

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Date of Approval

11/01/2023

Registration No.

SIN16673P

Indications:

Ulcerative Colitis

Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

Crohn’s Disease

Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

Product Name

NABOTA POWDER FOR SOLUTION FOR INJECTION 100 UNITS/VIAL

Active Ingredient

Clostridium Botulinum Toxin Type A

Application type

NDA-2: New biological product

Product Registrant

HYPHENS PHARMA PTE. LTD.

Date of Approval

20/01/2023

Registration No.

SIN16680P

Indications:

Temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) associated with corrugator muscle and/or procerus muscle activities, in adults below 65 years of age.

Product Name

FESPIXON CREAM

Active Ingredient

Centella asiatica extract, Plectranthus amboinicus

extract

Application type

NDA-1

Product Registrant

PHARMENG TECHNOLOGY PTE. LTD.

Date of Approval

31/01/2023

Registration No.

SIN16683P

Indications:

Diabetic foot ulcer

Note: The clinical trial results are based on the subjects with non-ischaemic Wagner Grade 1 and Grade 2 chronic diabetic foot ulcers without evidence of active infection.