New drug indication approval - April 2025
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | BOTOX® POWDER FOR SOLUTION FOR INJECTION 50 UNITS/VIAL,
BOTOX POWDER FOR SOLUTION FOR INJECTION 100 UNITS/VIAL,
BOTOX® POWDER FOR SOLUTION FOR INJECTION 200 UNITS/VIAL |
| Active Ingredient (Strength) | Clostridium Botulinum toxin type A(50 Units),
CLOSTRIDIUM BOTULINUM TOXIN TYPE A(100 units/vial),
Botulinum toxin type A(200 Units) |
| Product Registrant | ABBVIE PTE. LTD. |
| Date of Approval | 10/04/2025 |
Indications:
BOTOX® is indicated for the temporary improvement in marked* to very marked** benign masseter muscle hypertrophy (ie prominence) associated with masseter muscle activity in conditions such as bruxism in adults.
*Marked: With mouth closed and no clenching, surface overlying masseter is convex. The masseter muscle, in conjunction with the chin and jawline, creates a square lower facial contour. Masseter is palpable and firm. With clenching, the lower face is wider and squarer compared to when mouth is closed. Masseter is palpable and firm or hard.
**Very marked: With mouth closed and no clenching, surface overlying masseter is convex. The masseter muscle, in conjunction with the chin and jawline, creates a trapezoidal lower facial contour. Masseter is palpable and firm. With clenching, the lower face is more trapezoidal compared to when mouth is closed. Masseter is palpable and hard. |
| Product Name | BLINCYTO POWDER FOR INFUSION 35 MCG/VIAL |
| Active Ingredient (Strength) | Blinatumomab(55.0 μg/mL) |
| Product Registrant | AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD |
| Date of Approval | 28/04/2025 |
Indications:
BLINCYTO is indicated for the treatment of CD-19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older. *Evaluated via Project Orbis. |
| Product Name | FASENRA SOLUTION FOR INJECTION 30MG/ML (AUTOINJECTOR PEN),
FASENRA SOLUTION FOR INJECTION 30MG/ML (PRE-FILLED SYRINGE) |
| Active Ingredient (Strength) | Benralizumab(30 mg / ml),
Benralizumab(30 mg/ml) |
| Product Registrant | ASTRAZENECA SINGAPORE PTE LTD |
| Date of Approval | 21/04/2025 |
Indications:
FASENRA is indicated as an add-on treatment for adult patients with eosinophilic granulomatosis with polyangiitis. |
| Product Name | OLUMIANT FILM-COATED TABLET 4MG,
OLUMIANT FILM-COATED TABLET 2MG |
| Active Ingredient (Strength) | Baricitinib(4.000mg),
Baricitinib(2.000mg) |
| Product Registrant | DKSH SINGAPORE PTE. LTD. |
| Date of Approval | 09/04/2025 |
Indications:
Juvenile idiopathic arthritis
Baricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs:
- Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular),
- Enthesitis related arthritis, and
- Juvenile psoriatic arthritis.
Baricitinib may be used as monotherapy or in combination with methotrexate. Atopic dermatitis
Children and adolescents (2 years of age and older)
Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in paediatric
patients 2 years of age and older whose disease is not adequately controlled with conventional
topical and systemic prescription therapies or when those therapies are not advisable. |
| Product Name | JEMPERLI CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/10ML |
| Active Ingredient (Strength) | Dostarlimab(500mg/10mL) |
| Product Registrant | GLAXOSMITHKLINE PTE LTD |
| Date of Approval | 15/04/2025 |
Indications:
JEMPERLI is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. |
| Product Name | TRIMBOW PRESSURISED INHALATION SOLUTION 100/6/12.5 ΜG PER ACTUATION |
| Active Ingredient (Strength) | Beclometasone dipropionate anhydrous(0.1mg/actuation), Formoterol fumarate dihydrate(0.006mg/actuation), Glycopyrronium bromide(0.0125mg/actuation) |
| Product Registrant | ORIENT EUROPHARMA PTE LTD |
| Date of Approval | 30/04/2025 |
Indications:
Chronic obstructive pulmonary disease (COPD)
Maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).
Asthma
Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals