New drug indication approval - October 2024

Active Ingredient (Strength)

Clostridium Botulinum Toxin Type A(100 Units/vial)

Product Registrant

HYPHENS PHARMA PTE. LTD.

Date of Approval

17/10/2024

Indications:
4.1.2. Focal upper limb spasticity
Upper limb spasticity associated with stroke in adults aged over 18 years.
4.1.3. Lateral canthal lines (crow's feet lines)
Temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet lines) associated with orbicularis oculi muscle activity in adults below 65 years of age.
4.1.4. Blepharospasm
Treatment of benign essential blepharospasm in adults aged over 18 years 4.1.5. Benign masseter muscle hypertrophy (square jaw)
Temporary improvement in marked* to very marked** benign masseter muscle hypertrophy associated with conditions such as bruxism (including teeth clenching and grinding) in adults below 65 years of age.
* Marked:
At rest, the lower face contour, including the masseter muscle, jaw, and jawline, is square, and the surface of the masseter muscle is severely convex. At maximum clenching, the lower face contour shows a severe difference compared to at rest, and the masseter muscle mass is firm or hard and palpable.
** Very marked:
At rest, the lower face contour, including the masseter muscle, jaw, and jawline, is trapezoidal, and the surface of the masseter muscle is severely convex. At maximum clenching, the lower face contour shows a severe difference compared to at rest, and the masseter muscle is hard and palpable

Active Ingredient (Strength)

Ezetimibe(10.0 mg),Rosuvastatin Calcium eqv. Rosuvastatin(20.0 mg),
Ezetimibe(10.0 mg),Rosuvastatin Calcium eqv. Rosuvastatin(10.0 mg)

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

01/10/2024

Indications:
Primary Hypercholesterolaemia/Homozygous Familial Hypercholesterolaemia (HoFH)
Suvezen is indicated as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia in adult patient.
- who are not appropriately controlled with statin alone,
- who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the
same dose level as in the fixed combination, but as separate products

Active Ingredient (Strength)

Tipiracil hydrochloride 7.065mg eqv Tipiracil(6.14mg),Trifluridine(15mg),
Tipiracil hydrochloride 9.420mg eqv Tipiracil(8.19mg),Trifluridine(20mg)

Product Registrant

TAIHO PHARMA ASIA PACIFIC PTE. LTD.

Date of Approval

29/10/2024

Indications:
Lonsurf® is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with:
• metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1)
•metastatic gastric or gastroesophageal junction adenocarcinomawho have been previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.