New SFDA Drug Approvals

Request Type

Drug Type

Trade Name

Scientific Name

Strength

Dosage Form

Approval Date

SFDA Approved Use

Registration

Biological Drug

Tzield

Teplizumab

1 mg/ml

Solution for injection

2025-03-01

SFDA Approved Use


SFDA Approved Use	Teplizumab is indicated to delay the of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes

Registration

Biological Drug

Ebglyss

Lebrikizumab

250 mg/2 mL

Solution for injection

2025-03-01

SFDA Approved Use


SFDA Approved Use	It is used for the treatment of adult and adolescent patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It can be used with or without topical corticosteroids.

New Registration

Generic

Quillivant XR

Methylphenidate

30 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.

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.

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

Donfer

Pirfenidone

267 mg

Film-coated tablet

2025-03-01

SFDA Approved Use


SFDA Approved Use	Indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF)

New Registration

Generic

Donfer

Pirfenidone

801 mg

Film-coated tablet

2025-03-01

SFDA Approved Use


SFDA Approved Use	Indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF)

New Registration

Generic

Donfer

Pirfenidone

2025-03-01

SFDA Approved Use


SFDA Approved Use	Indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF)