New SFDA Drug Approvals

Request Type

Drug Type

Trade Name

Scientific Name

Strength

Dosage Form

Approval Date

SFDA Approved Use

New Registration

Generic

Dimex

Dimetindene Maleate

0.1 %

Gel

2025-02-01

SFDA Approved Use


SFDA Approved Use	Local treatment of itching in skin diseases, insect bites, minor burns, and sunburn.

New Registration

Generic

Paricalcitol Spectro

Paricalcitol

5 µg/ml

Solution for injection

2025-02-01

SFDA Approved Use


SFDA Approved Use	Indicated in adults for the prevention and treatment of secondary hyperparathyroidism in patients with chronic renal failure who are undergoing haemodialysis.

New Registration

Generic

Filozad

Carfilzomib

60 mg

Powder for solution for injection

2025-02-01

SFDA Approved Use


SFDA Approved Use	Carfilzomib indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with: Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone. Carfilzomib indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

Registration

Generic Drug

Sefarix

Cefdinir

300 mg

Capsule

SFDA Approved Use


SFDA Approved Use	To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Adults and Adolescents Community-Acquired Pneumonia Caused by Haemophilusinfluenzae (including β-lactamase producing strains),Haemophilusparainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae(penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Acute Exacerbations of Chronic Bronchitis caused by Haemophilusinfluenzae (including β-lactamase producing strains),Haemophilusparainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae(penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Acute Maxillary Sinusitis caused by Haemophilusinfluenzae (including β-lactamase producing strains), Streptococcuspneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). NOTE: For information on use in pediatric patients. Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes . NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenespharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcuspyogenes. Pediatric Patients Acute Bacterial Otitis Media caused by Haemophilusinfluenzae (including β-lactamase producing strains), Streptococcuspneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenespharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcuspyogenes.

Registration

Generic Drug

Tagbro

Ticagrelor

90 mg

Film-Coated tablet

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

Olmexa

Olmesartan Medoxomil, Amlodipine Besylate

20 mg, 5 mg

Film-coated tablet

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.

New Registration

Generic(Multisource) Drug

Tasylev

semaglutide

0.25 mg

Solution for injection in pre-filled pen

SFDA Approved Use


SFDA Approved Use	Tasylev is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise •As monotherapy when metformin is considered inappropriate due to intolerance or contraindications •In addition to other medicinal products for the treatment of diabetes. •Tasylev is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.