List of 2023 Approved Drugs in India

List of 2023 Approved Drugs in India

The list of the 2023 approved drugs in India is mentioned below. To know the name of the drugs and indication of the medicine, their date of issuance is also listed under the given table. Check out the Q & A as it covers all your queries, and you will get your solutions. Approved Drugs in India

S.No Name of the Drugs Indication  Date of Issue
1 Fesoteroterodine Fumarate Extended Release Tablets 4mg and 8mg and Fesoteroterodine Fumarate Bulk As a decorporation agent indicated the 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. 06-01-2023
2 Trifarotene 50 microgram/g (0.005% w/w) Cream  Indicated for topical treatment of mild to moderate atopic dermatitis in adult andpaediatric patients 2 years of age andolder 13-01-2023
3 Crisaborole Ointment 2%              Indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. 20-01-2023
4 Prussian Blue Insoluble 340 mg and Magnesium Hydroxide 500 mg Capsule A decorporation agent is indicated for the treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or nonradioactive thallium to increase their rates of elimination.  20-01-2023
5 Prussian Blue Insolube 340 mg Capsule and Prussian Blue Insolube Bulk Drug Indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 2 years of age and older 27-01-2023
6 Imeglimin Hydrochloride Tablet 500mg/1000mg Type 2 diabetes Mellitus 06-01-2023
7 Crisaborole Bulk Drug  As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatients and outpatient procedures.For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of ananestesia practitioner inpostoperativeanesthesia care unit or intensive care setting.As an analgesic component of monitored anesthesia care in adult patients. 10-02-2023
8 Remifentanil Hydrochloride 1mg/2mg for Injection 3-(trimethoxysilyl)propyl dimethyl octadecyl ammonium chloride , Benzalkonium chloride, &Didecyl Dimethyl ammonium chloride  15-02-2023
9 Cannabidiol Bulk Drug, Cannabidiol Oral Solution 100mg/ml  Indicated for the treatment of seizures associated with Lennox Gastautsyndrome, Dravet Syndrome, or tuberous sclerosis complex in patients 1 year of age and older 06-04-2023
10 For the symptomatic relief of mild to moderate pain such as headache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, migraines, cold and flu symtoms, sore throat and fever For surface Disinfectant and Hand Sanitizer 24.04.2023
11 Ibuprofen Sodium Dihydrate Bulk Drug, Ibuprofen Sodium Dihydrate 256/512mg Tablet Niraparib is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO stage-III and IV) highgrade 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 platinumsensitive relapsed high grade serous epithelial ovarian, fallopian tube , or primary peritoneal cancer who are in response (complete or partia) to platinumbased chemotherapy 26.04.2023
12 Niraparib Tablet 100mg 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 anginosusgroup (including S. anginosus, S. intermedius,S. constellatus) and Enterococcus faecalis (vancomycin susceptible strains). 01.05.2023
13 Polmacoxib Bulk Drug, Polmacoxib Capsule 2mg  Indicatged for treatment of Idiopathic (primary) osteoarthritis of Hip/Knec 01.05.2023
14 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
15 Squaric Acid 0.748 mg/ml&Squaric Acid 1.745 mg/ml Solution (Spray)  Disinfection of Inanimate surface likefloor, toilet, garbage areas only 04.05.2023
16 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 anginosusgroup (including S. anginosus, S. intermedius,S. constellatus) and Enterococcus faecalis (vancomycin susceptible strains). 23.05.2023
17 LobeglitazoneSulfate 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
18 Sovateltide Bulk Drug &Sovateltide Injection 30 µg Cerebral ischemic Stroke. 31.05.2023
19 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 
20 Plecanatide Bulk Drug&Plecanatide Tablets 3mg 1.) Chronic idiopathic constipation (CIC) 2.) Irritable bowel syndrome with constipation (IBS-C) 08.06.2023 
21 Treprostinil Bulk Drug andTreprostinil 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 
22 Icaridin API and Icaridin 20% w/v Spray Indicated for mosquito and insect repellent  19-09-2023
23 Inclisiran solution for injection in prefilled syringe 284 mg/1.5 ml Inclisiran is indicated in adults with primary hypercholesterolemia (heterozygous familial and nonfamilial) 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
24 Relugolix Bulk Drug and Relugolix Tablet 120mg For the treatment of adult patients with advance prostate cancer 16-10-2023
25 Asciminib film-coated 20mg and 40 mg tablets Asciminib is indicated for the treatment of adult patients with: – Philadelphia chromosome-positive  chronic myeloid leukemia (Ph+CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs) -Ph+CML in CP with the T315I mutation  20.10.2023
26 Lasmiditan Hemisuccinate Bulk Drug & Lasmiditan Tablet 50mg/100mg  Indicated for the acute treatment ofmigraine with or without aura in adult 29.11.2023
27 Abrocitinib Tablets 50mg, 100mg & 200mg Indicated for the treatment of adults with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other with other systemic drug products, including biologics, or when use of those therapies is inadvisable  29.11.2023

What Is The New Drug Approved By CDSCO In 2023?

Remifentanil Hydrochloride 1mg/2mg for Injection is the new drug approved by CDSCO  in 2023. To know the process of the drug approval click on this.

How are Drugs Approved In India?

Drugs approved in india get the green list from the DCG office; DCG is the main authority that provides approval for the manufacture or import of new drugs for marketing in the country itself.

Which Indian Drug Is Approved By The FDA?

Centhaquin is the first ever indian drug approved by the FDA, widely known as Food and Drug Administration. 

What Are The Three Pillars Of Drug Discovery?

Non-clinical, Clinical, and Quality are the three major pillars of drug discovery.

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