New SFDA Drug Approvals

Request Type

Drug Type

Trade Name

Scientific Name

Strength

Dosage Form

Approval Date

SFDA Approved Use

Registration

Generic Drug

Toxefro

Deferasirox

500 mg

Film-Coated tablet

2025-04-01

SFDA Approved Use


SFDA Approved Use	Deferasirox is indicated for the treatment of chronic iron overload due to frequentblood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with betathalassemia major aged 6 years and older. Deferasirox is also indicated for the treatment of chronic iron overload due to bloodtransfusions when deferoxamine therapy is contraindicated or inadequate in the followingpatient groups: -in pediatric patients with beta thalassemia major with iron overload due tofrequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years

Registration

Generic Drug

Amiroic

Aminocaproic Acid

1.25 g/5 ml

Oral Solution

2025-04-01

SFDA Approved Use


SFDA Approved Use	Aminocaproic acid is indicated for use in patients of all ages in haemorrhage caused by local or general fibrinolysis, including in Postsurgical haemorrhages in: •Urology (surgery of the bladder and prostate) •Gynaecology (cervical surgery), in patients where tranexamic acid is not available or not tolerated •Obstetrics (post-partum and post-miscarriage haemorrhages) after correction of the coagulation defect •Heart surgery (with or without bypass placement) •Gastroenterology •Odonto-stomatology (dental extractions in haemophiliacs, patients undergoing anticoagulanttherapy) Life-threatening haemorrhages induced by thrombolytics (streptokinase, etc.). Haemorrhages associated with thrombocytopenia, thrombopenic purpura, leukaemia. Nonsurgical haematuria of the lower urinary tract (secondary to cystitis, etc.). Intense menstruations, menorrhagia and haemorrhagic metropathies. Angioneurotic oedema.

Registration

Generic Drug

Promazi

Chlorpromazine Hydrochloride

25 mg

Film-Coated tablet

2025-04-01

SFDA Approved Use


SFDA Approved Use	Schizophrenia and other psychoses (especially paranoia), mania and hypomania. In anxiety, psychomotor agitation, excitement, violent or dangerously impulsive behavior. Is used as an adjunct in the short-term management of these conditions. ·Intractable hiccup. ·Nausea and vomiting in terminal illness (where other drugs have failed or are not available). ·Induction of hypothermia is facilitated by Chlorpromazine Tablets which prevents shivering and causes vasodilatation. Childhood schizophrenia and autism

Registration

Generic Drug

Promazi

Chlorpromazine Hydrochloride

50 mg/2 ml

Solution for injection

2025-04-01

SFDA Approved Use


SFDA Approved Use	Chlorpromazine Hydrochloride is intended for the following indications: treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.

Registration

Generic Drug

Promazi

Chlorpromazine Hydrochloride

50 mg/2 ml

Solution for infusion

2025-04-01

SFDA Approved Use


SFDA Approved Use	Chlorpromazine Hydrochloride is intended for the following indications: treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.

Registration

Generic Drug

Docetere

Docetaxel Trihydrate

80 mg / 4 ml

Solution for infusion

2025-04-01

SFDA Approved Use


SFDA Approved Use	Breast cancer Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: • operable node-positive breast cancer • operable node-negative breast cancer For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1). Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small cell lung cancer Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. Gastric adenocarcinoma Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease Head and neck cancer Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck

New Registration

Generic

Dexrofex

Deferasirox

90 mg

Film-coated tablet

2025-03-01

SFDA Approved Use


SFDA Approved Use	Indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. Dexrofex is also indicated for the treatment of chronic iron overload due to blood transfusions when Feroxamine therapy is contraindicated or inadequate in the following patient groups: - in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 years and older. Ferox is also indicated for the treatment of chronic iron overload requiring chelation therapy when Feroxamine therapy is contraindicated or inadequate in patients with non-transfusion- dependent thalassaemia syndromes aged 10 years and older.

New Registration

Generic

Dunarez

Darunavir

400 mg

Film-coated tablet

2025-03-01

SFDA Approved Use


SFDA Approved Use	Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir, co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) Darunavir 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: Antiretroviral therapy (ART)-naïve • ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/L. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir

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

Omacillin

Amoxicillin

250 mg

Capsule

2025-03-01

SFDA Approved Use


SFDA Approved Use	Omacillin capsules is indicated for the treatment of the following infections in adults and children: •Acute bacterial sinusitis •Acute otitis media •Acute streptococcal tonsillitis and pharyngitis •Acute exacerbations of chronic bronchitis •Community acquired pneumonia •Acute cystitis •Asymptomatic bacteriuria in pregnancy •Acute pyelonephritis •Typhoid and paratyphoid fever •Dental abscess with spreading cellulitis •Prosthetic joint infections •Helicobacter pylori eradication •Lyme disease Omacillin capsule is also indicated for the prophylaxis of endocarditis.