New SFDA Drug Approvals

Request Type

Drug Type

Trade Name

Scientific Name

Strength

Dosage Form

Approval Date

SFDA Approved Use

Registration

Generic Drug

Carfilzomib BOS

Carfilzomib

10 mg

Lyophilized powder for solution for injection

2025-05-01

SFDA Approved Use


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

Registration

Generic Drug

Sildenafil Amarox

Sildenafil

10 mg/ml

Powder for oral suspension

2025-05-01

SFDA Approved Use


SFDA Approved Use	Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease

Registration

Generic Drug

Itranox

Itraconazole

10 mg/ml

Oral Solution

2025-05-01

SFDA Approved Use


SFDA Approved Use	Itraconazole Oral Solution is indicated: - for the treatment of oral and/or oesophageal candidosis in HIV-positive or other immunocompromised patients. - as prophylaxis of deep fungal infections anticipated to be susceptible to itraconazole, when standard therapy is considered inappropriate, in patients with haematological malignancy or undergoing bone marrow transplant, and who are expected to become neutropenic (i.e. < 500 cells/μL). At present, there are insufficient clinical efficacy data in the prevention of aspergillosis. Consideration should be given to national and/or local guidance regarding the appropriate use of antifungal agents.

Registration

Generic Drug

Rufzel

Rufinamide

200 mg

Film coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.

Registration

Generic Drug

Rufzel

Rufinamide

400 mg

Film coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.

Registration

Generic Drug

Risek Plus

Omeprazole, Sodium Bicarbonate

40 mg, 1100 mg

Immediate release hard gelatin Capsules

2025-05-01

SFDA Approved Use


SFDA Approved Use	Risek Plus capsules are indicated in adults for the: - short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. - short-term treatment (4 to 8 weeks) of active benign gastric ulcer. - treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. - short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. - The efficacy of Omeprazole/ Sodium bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Risek Plus may be considered. - maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.

Registration

Generic Drug

Endura

Dapoxetine Hydrochloride

60 mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Dapoxetine Hydrochloride is indicated for the treatment of premature ejaculation (PE) in adult men 18 to 64 years. Dapoxetine Hydrochloride should only be prescribed to patients who meet all the following criteria: • An intravaginal ejaculatory latency time (IELT) of less than two minutes. • Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes. • Marked personal distress or interpersonal difficulty as a consequence of PE. • Poor control over ejaculation. • A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months. Dapoxetine should be administered only as on-demand treatment before anticipated sexual activity. Dapoxetine should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.

Generic Drug

Endura

Dapoxetine Hydrochloride

30 mg

Film-coated tablet

2025-05-01

SFDA Approved Use


SFDA Approved Use	Dapoxetine Hydrochloride is indicated for the treatment of premature ejaculation (PE) in adult men 18 to 64 years. Dapoxetine Hydrochloride should only be prescribed to patients who meet all the following criteria: • An intravaginal ejaculatory latency time (IELT) of less than two minutes. • Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes. • Marked personal distress or interpersonal difficulty as a consequence of PE. • Poor control over ejaculation. • A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months. Dapoxetine Hydrochloride should be administered only as on-demand treatment before anticipated sexual activity. Dapoxetine should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.

Registration

Biological Drug

Acura

Bevacizumab

400 mg/ 16ml

Concentrate for solution for infusion

2025-05-01

SFDA Approved Use


SFDA Approved Use	Metastatic Colorectal Cancer (mCRC) • Bevacizumab in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC). • Bevacizumab in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use: Bevacizumab is not indicated for adjuvant treatment of colon cancer. First-Line Non-Squamous Non–Small Cell Lung Cancer (NSCLC) • Bevacizumab in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC). Recurrent Glioblastoma (GBM) • Bevacizumab is indicated for the treatment of recurrent glioblastoma (GBM) in adults. Metastatic Renal Cell Carcinoma (mRCC) • Bevacizumab in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). Persistent, Recurrent, or Metastatic Cervical Cancer • Bevacizumab in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer • Bevacizumab in combination with carboplatin and paclitaxel, followed by Acura® as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. • Bevacizumab in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. • Bevacizumab in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Acura® as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Hepatocellular Carcinoma (HCC) • Bevacizumab in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Registration

Biological Drug

Acura

Bevacizumab

100 mg/ 4ml

Concentrate for solution for infusion

2025-05-01

SFDA Approved Use


SFDA Approved Use	Metastatic Colorectal Cancer (mCRC) • Bevacizumab in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC). • Bevacizumab in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use: Bevacizumab is not indicated for adjuvant treatment of colon cancer. First-Line Non-Squamous Non–Small Cell Lung Cancer (NSCLC) • Bevacizumab in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC). Recurrent Glioblastoma (GBM) • Bevacizumab is indicated for the treatment of recurrent glioblastoma (GBM) in adults. Metastatic Renal Cell Carcinoma (mRCC) • Bevacizumab in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). Persistent, Recurrent, or Metastatic Cervical Cancer • Bevacizumab in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer • Bevacizumab in combination with carboplatin and paclitaxel, followed by Acura® as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. • Bevacizumab in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. • Bevacizumab in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Acura® as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Hepatocellular Carcinoma (HCC) • Bevacizumab in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.