New SFDA Drug Approvals

Request Type

Drug Type

Trade Name

Scientific Name

Strength

Dosage Form

Approval Date

SFDA Approved Use

Registration

Generic Drug

Olmexa

Olmesartan Medoxomil, Amlodipine Besylate

20mg, 10mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Treatment of essential hypertension. is indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy.

Registration

Generic Drug

Olmexa

Olmesartan Medoxomil, Amlodipine Besylate

40mg, 5 mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Treatment of essential hypertension. is indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy.

Registration

Generic Drug

Olmexa

Olmesartan Medoxomil, Amlodipine Besylate

40mg, 10mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Treatment of essential hypertension. is indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy.

Registration

Generic Drug

Monovira

Efavirenz

600 mg

Film coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus 1 (HIV 1) infected adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg. Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm 3, or after failure of protease inhibitor (PI) containing regimens. Although cross resistance of Efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing Efavirenz. For a summary of clinical and pharmacodynamic information.

Registration

Generic Drug

Olmesartan Medoxomil, Amlodipine Besylate, Hydrochlorothiazide

40mg, 5mg, 12.5 mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Treatment of essential hypertension. AMOTAN-H FC TABLET Add-on therapy OLMEXA PLUS is indicated in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation. Substitution therapy OLMEXA PLUS is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (Olmesartan medoxomil and amlodipine or olmesart

Registration

Generic Drug

Olmexa Plus

Olmesartan Medoxomil, Amlodipine Besylate, Hydrochlorothiazide

40mg, 10mg, 12.5 mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Treatment of essential hypertension. AMOTAN-H FC TABLET Add-on therapy OLMEXA PLUS is indicated in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation. Substitution therapy OLMEXA PLUS is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (Olmesartan medoxomil and amlodipine or olmesart

Registration

Generic Drug

Olmexa Plus

Olmesartan Medoxomil, Amlodipine Besylate, Hydrochlorothiazide

20mg, 5mg, 12.5 mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Treatment of essential hypertension. AMOTAN-H FC TABLET Add-on therapy OLMEXA PLUS is indicated in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation. Substitution therapy OLMEXA PLUS is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (Olmesartan medoxomil and amlodipine or olmesart

Registration

Generic Drug

Olmexa Plus

Olmesartan Medoxomil, Amlodipine Besylate, Hydrochlorothiazide

40mg, 10mg, 25mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Treatment of essential hypertension. AMOTAN-H FC TABLET Add-on therapy OLMEXA PLUS is indicated in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation. Substitution therapy OLMEXA PLUS is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (Olmesartan medoxomil and amlodipine or olmesart

Registration

Generic Drug

Ticaglob

Ticagrelor

90 mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Ticagrelor co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with - Acute coronary syndromes (ACS) or - A history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.

Registration

Generic Drug

Zylinamet

Linagliptin, Metformin HCL

2.5mg, 850mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Zylinamet is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: ·In patients inadequately controlled on their maximally tolerated dose of metformin alone ·In combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products ·In patients already being treated with the combination of linagliptin and metformin as separate tablets.