Drug Approvals
Latest Drug Approvals
| Name of drug | Indication | Date of issue |
|---|---|---|
| Solution 100mg/ml | syndrome, Dravet Syndrome, or tuberous sclerosis complex in patients 1 year of age and older | |
| group (including S. anginosus, S. intermedius,S. constellatus) and Enterococcus faecalis (vancomycin susceptible strains). | ||
| Niraparib Tablet 100mg | Niraparib is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO stage-III and IV) high- grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum -based chemotherapy. as monotherapy for the maintenance treatment of adult patients with platinum- sensitive relapsed high grade serous epithelial ovarian, fallopian tube , or primary peritoneal cancer who are in response (complete or partia) to platinum- based chemotherapy | 01-05-2023 |
| Polmacoxib Bulk Drug, Polmacoxib Capsule 2mg | Indicatged for treatment of Idiopathic (primary) osteoarthritis of Hip/Knec | 01-05-2023 |
| Amines, N- C10-16-alkyl trimethylenedi-, reaction products with chloro acetic acid 1.0000% w/w | Surface celaning, aerial Misting, Hand Sanitization (Not for covid use) | 04-05-2023 |
| Squaric Acid 0.748 mg/ml & Squaric Acid 1.745 mg/ml Solution (Spray) | Disinfection of Inanimate surface like floor, toilet, garbage areas only | 04-05-2023 |
| Lifitegrast Bulk drug & Lifitegrast Ophthalmic Solution 5%w/v | Indicated for the treatment of signs and symptoms of dry eye disease (DED) | 05-06-2023 |
| Fesoteroterodine Fumarate Extended Release Tablets 4mg and 8mg and Fesoteroterodine Fumarate Bulk | Indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. | 06-01-2023 |
| Imeglimin Hydrochloride Tablet 500mg/1000mg | Type 2 diabetes Mellitus | 06-01-2023 |
| Cannabidiol Bulk Drug, Cannabidiol Oral | Indicated for the treatment of seizures associated with Lennox- Gastaut | 06-04-2023 |
| Plecanatide Bulk Drug & Plecanatide Tablets 3mg | 1.) Chronic idiopathic constipation (CIC) 2.) Irritable bowel syndrome with constipation (IBS-C) | 08-06-2023 |
| Crisaborole Bulk Drug | Indicated for topical treament of mild to moderate atopic dermatitis in adult and pediatric patients 2 years of age and older | 10-02-2023 |
| Trifarotene 50 microgram/g (0.005% w/w) Cream | Indicated for the cutaneous treatment of Acne Vulgaris of the face and /or trunk in patients 12 years of age and older. | 13-01-2023 |
| Remifentanil Hydrochloride 1mg/2mg for Injection | As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anestesia practitioner in a posto perative anesthesia care unit or intensive care setting. As an analgesic component of monitored anesthesia care in adult patients. | 15-02-2023 |
| Relugolix Bulk Drug and Relugolix Tablet 120mg | For the treatment of adult patients with advance prostate cancer | 16-10-2023 |
| Icaridin API and Icaridin 20% w/v Spray | Indicated for mosquito and insect repellent | 19-09-2023 |
| Crisaborole Ointment 2% | Indicated for topical treatment of mild to moderate atopic dermatitis in adult and paediatric patients 2 years of age and older | 20-01-2023 |
| Prussian Blue Insoluble 340 mg and Magnesium Hydroxide 500 mg Capsule | As decorporation agent indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non radioactive thallium to increase their rates of elimination. | 20-01-2023 |
| Inclisiran solution for injection in prefilled syringe 284 mg/1.5 ml | Inclisiran is indicated in adults with primary hypercholesterolemia (heterozygous familial and non- familial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goal with the maximum tolrated dose of a statin, or - alone or in combination with other lipid lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated | 22-09-2023 |
| Dalbavancin Hydrochloride Bulk Drug, Dalbavancin Injection 500mg | Dalbavancin for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following Gram-positive microorganisms staphylococcus aureus (including methicillin susceptible and methicillin resistant strains), streptococcus pyogenes, streptococcus agalactiae, streptococcus dysgalactiae, streptococcus anginosus | 23-05-2023 |
| Lobeglitazone Sulfate 0.5mg+Glimepiride 1mg Tablets | Indicated an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulphorylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulphonylurea alone. | 23-05-2023 |
| 3-(trimethoxysilyl)propyl dimethyl octadecyl ammonum chloride , Benzalkonium chloride, & Didecyl Dimethyl ammonium chloride | For surface Disinfectant and Hand Sanitizer | 24-04-2023 |
| Ibuprofen Sodium Dihydrate Bulk Drug, Ibuprofen Sodium Dihydrate 256/512mg Tablet | For the symptomatic relief of mild to moderate pain such as headache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, migrane, cold and flu symtoms, sore throat and fever | 26-04-2023 |
| Prussian Blue Insolube 340 mg Capsule and Prussian Blue Insolube Bulk Drug | As decorporation agent indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non radioactive thallium to increase their rates of elimination. | 27-01-2023 |
| Treprostinil Bulk Drug and Treprostinil Solution for infusion 1mg/ml & 10mg/ml | For the treatment of idiopathic or heritable pulmonary arterial hypertension (PAH) to improve exercise tolerance and symptoms of disease in patients classified as New York Heart Association (NYHA) functional class III | 27-07-2023 |
| Sovateltide Bulk Drug & Sovateltide Injection 30 µg | Cerebral ischemic Stroke. | 31-05-2023 |
