New SFDA Drug Approvals

Request Type

Drug Type

Trade Name

Scientific Name

Strength

Dosage Form

Approval Date

SFDA Approved Use

Registration

Generic Drug

LAXIRA

Rocuronium Bromide

10 mg/ml

Solution for injection

2025-04-01

SFDA Approved Use


SFDA Approved Use	Rocuronium bromide is indicated in adult and pediatric patients (from term neonates to adolescents [0 to <18 years]) as an adjunct to general anesthesia to facilitate tracheal intubation during routine induction and to provide skeletal muscle relaxation during surgery. In adults, Rocuronium bromide is also indicated to facilitate tracheal intubation during rapid sequence induction and as an adjunct in the intensive care unit (ICU) (to facilitate intubation), for short term use

Registration

Generic Drug

Arsenic trioxide

1 mg/ml

Concentrate for solution for infusion

2025-04-01

SFDA Approved Use


SFDA Approved Use	Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103 /µl) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Registration

Generic Drug

Restain

Methylcobalamin

500 mcg

Film-coated tablet

2025-04-01

SFDA Approved Use


SFDA Approved Use	Peripheral neuropathies.

Registration

Generic Drug

Sola D3

Cholecalciferol

5000 IU

Film-coated tablet

2025-04-01

SFDA Approved Use


SFDA Approved Use	The treatment and prevention of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency. Cholecalciferol tablets are indicated for use in adults, the elderly and adolescents.

Registration

Generic Drug

Sola D3

Cholecalciferol

10000 IU

Film-coated tablet

2025-04-01

SFDA Approved Use


SFDA Approved Use	The treatment and prevention of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency. Cholecalciferol tablets are indicated for use in adults, the elderly and adolescents.

New Registration

Generic

Provecta

Brivaracetam

100 mg

Film-coated tablet

2025-03-01

SFDA Approved Use


SFDA Approved Use	Provecta is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.

New Registration

Generic

Sitaglu

Sitagliptin Hydrochloride

100 mg

Film-coated tablet

2025-03-01

SFDA Approved Use


SFDA Approved Use	For adult patients with type 2 diabetes mellitus, Sitaglu is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e. a thiazolidinedione) when use of a PPARg agonist is appropriate and when diet and exercise plus the PPARg agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. a PPARg agonist and metformin when use of a PPARg agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin beta is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

New Registration

Generic

Sitaglu

Sitagliptin Hydrochloride

50 mg

Film-coated tablet

2025-03-01

SFDA Approved Use


SFDA Approved Use	For adult patients with type 2 diabetes mellitus, Sitaglu is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e. a thiazolidinedione) when use of a PPARg agonist is appropriate and when diet and exercise plus the PPARg agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. a PPARg agonist and metformin when use of a PPARg agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin beta is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

New Registration

Generic

Sitaglu

Sitagliptin Hydrochloride

25 mg

Film-coated tablet

2025-03-01

SFDA Approved Use


SFDA Approved Use	For adult patients with type 2 diabetes mellitus, Sitaglu is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e. a thiazolidinedione) when use of a PPARg agonist is appropriate and when diet and exercise plus the PPARg agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. a PPARg agonist and metformin when use of a PPARg agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin beta is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

New Registration

Generic

Quillivant XR

Methylphenidate

20 mg

Film-coated tablet

2025-03-01

SFDA Approved Use


SFDA Approved Use	Indicated as part of a comprehensive treatment program for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age and over and adults when remedial measures alone prove insufficient.