S.No | Name of drug | Indication | Date of issue |
1 | Cidofovir dihydrate bulk drug and Cidofovir injection 75 mg/ ml (5 ml single use vial) | Cidofovir is indicated for the treatment of CMV retinitis in adults with acquired immune defeciency syndrome (AIDS) and without renal dysfunction. It should be used only when other medicinal products are considered as unsuitable. | 03.01.2020 |
2 | Dacomitinib tablet 15mg, 30mg and 45mg | For the first line treatmrnt of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations | 03.01.2020 |
3 | Alpelisib film coated tablets 50mg, 150mg, 200mg | Alpelisib is a kinase inhibitor indicated in combination with Fulvestrant for the treatment of postmenopausal women, and men, with Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. | 03.01.2020 |
4 | Isavuconazolesulfate 100mg capsules | Indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis | 14.02.2020 |
5 | Azelnidipine tablets IP 8 mg | For the treatment of Stage I Hypertension | 04.03.2020 |
6 | Riboflavin Ophthalmic Solution 0.1% | It is intended to treat keratoconus and corneal ecstasia following refractive surgery | 11.03.2020 |
7 | Pixantrone 29mg powder for concentrate for solution for infusion | Indicated as 3rd line and 4th line therapy for the treatment of adult patients with multiply relapsed or refractory aggresive Non-Hodgkins B- Cell Lymphomas (NHL) | 11.03.2020 |
8 | FDC of Bilastine 20mg and Montelukast 10mg tablets | Indicated for the treatment of allergic rhinitis in adults. | 11.03.2020 |
9 | Obeticholic acid bulk drug and Obeticholic acid 5mg/10mg tablets | For the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with | 11.03.2020 |
ursodeoxycholic acid (UDCA) in adult with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA | |||
10 | Isavuconazole (as Isavuconazoniumsulfate) 200mg powder for concentrate for solution for infusion | Indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis | 11.03.2020 |
11 | Polymyxin B for injection 500000 IU | Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Ps. Aeruginosa. It may also be used as subconjuctival infection in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa. It may be indicated in serious infections caused by susceptibel strains of the following organisms, H. influenzae, specifically meningeal infectionsEscherichia coli, specifically urinary tract infectionsAerobacter aerogenes, specifically bacteremiaKlebsiella pneumoniae, specifically bacteremia | 30.03.2020 |
12 | Sucroferric oxyhydroxide bulk and Sucroferric oxyhydroxide chewabale tablet 500mg | Phosphate binder indicated for the control of serum phosphorous levels in patients with chronic kidney disease on dialysis | 18.04.2020 |
13 | Hydrogen peroxide 0.5% w/w wipes | Cleans, disinfects and deodorizes hard non- porous inanimate environmental surfaces | 29.04.2020 |
14 | Centhaquine citrate bulk and Centhaquine citrate injection 1.0mg/vial | Add on resuscitative agent for hypovolemic shock | 14.05.2020 |
15 | Hydrogen peroxide 0.5% w/w spray | Cleans, disinfects and deodorizes hard non- porous inanimate environmental surfaces | 28.05.2020 |
16 | Remdesivir Injection 5 mg/mL and Remdesivir lyophilised powder for Injection 100 mg | For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID-19) in adults and children hospitalised with severe disease, in light of Covid 19 outbreak, for restricted emergency use in the country. | 01.06.2020 |
17 | Lymphoseek 50mcg kit (each kit contains : Tilmanocept 50mcg, Glycine 0.1mg, Sodium ascorbate 0.1mg, Trehalose dihydrate 16mg, stannous chloride dihydrate 0.015mg, sodium hydoxideq.s, hydrochloric acid q.s, Nitrogen q.s, water for injection q.s) | Indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. This medicinal product is for diagnostic only. | 04.06.2020 |
18 | Favipiravir bulk and Favipiravir film coated tablet 200mg | For the treatment of patients with mild to moderate Covid-19 disease, in light of Covid 19 outbreak, for restricted emergency use in the country. | 19.06.2020 |
19 | Remdesivir bulk drug | – | 20.06.2020 |
20 | Propylene glycol 0.6% lubricant eye drops | Dry eye therapy for the temporary relief of burning and irritation due to dryness of the eye | 30.06.2020 |
21 | Pretomanid bulk and Pretomanid tablets 200mg | Indicated as part of a combination regimen with Bedaquiline and Linezolid, in adults for the treatment of pulmonary extensively drug resistant (XDR), or treatment intolerant or nonresponsive multidrug- resistant (MDR) tuberculosis (TB) | 15.07.2020 |
22 | Favipiravir film coated tablet 400mg | For the treatment of patients with mild to moderate Covid-19 disease, in light of Covid 19 outbreak for restricted emergency use in the country | 22.07.2020 |
23 | n-alkyl dimethyl benzyl ammonium chloride 0.105% w/w spray | Cleans, disinfects, deodorizes hard, non- porous inanimate environmental surfaces | 31.07.2020 |
24 | Defetilide bulk and Dofetilide capsules 125mcg, 250mcg, 500mcg | Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/ atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because Dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for | 31.07.2020 |
atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients. Conversion of Atrial Fibrillation/Flutter Dofetilide is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide has not been shown to be effective in patients with paroxysmal atrial fibrillation. | |||
25 | Octyl decyl dimethyl ammonium chloride 6.670% spray | Cleans, disinfects, deodorizes hard, non- porous inanimate environmental surfaces | 07.08.2020 |
26 | Carbetocin bulk and Carbetocin injection 100 mcg/ml | Prevention of postpartum haemorrhage due to uterine atony | 21.09.2020 |
27 | Netarsudil mesylate bulk and Netarsudil ophthalmic solution 0.02%w/v | For the reduction of elevated intraocular pressure in patients with open angle galucoma or ocular hypertension | 14.10.2020 |
28 | Risdiplam powder for oral solution 60mg | For treatment of Spinal Muscular Atrophy (SMA) in patients 2 months of age and older | 16.10.2020 |
29 | FDC of Azelnidipine 8mg and Telmisartan 40mg tablet | For the treatment of Stage-II hypertension | 16.10.2020 |