New Drugs List 2021& 2022 approved by CDSCO

 New Drugs List 2021& 2022 approved by CDSCO

The Central Drugs Standard Control Organization (CDSCO) issued another new drug approval list for the years 2021 and 2022, In these two years, CDSCO issued two new drugs the first new drug released on 26th February 2021, and the second new drug released on 12th March 2021. September. In this year till now, only two new drugs are declared by the central agency. The new drugs list 2021 will be updated as the new formulations will be issued by CDSCO by the year-end.

In 2022 the first New drug was issued on 20.01.2022 and the last one on 03.03.2022.

Also Read: New drugs list 2020

New drugs list 2022  S.NoName of drugIndicationDate of

issue1Triamcinolone Hexacetonide injectable suspension

20mg/mlFor intraarticular, intra-synovial or

periarticular use in adults and adolescents for the symptomatic treatment of subacute and chronic inflammatory joint diseases including rheumatoid arthritis and Juvenile Idiopathic

Arthritis (JIA), Osteoarthritis and posttraumatic arthritis, Synovitis, tendinitis, bursitis, and epicondylitis.20.01.20222Gimeracil bulk & Oteracil potassium bulk and

Tegafur 15mg/20mg, Gimeracil 4.35mg/5.8mg and

Oteracil 11.8mg/15.8mg capsulesindicated in adults for the treatment of

advanced gastric cancer when given in

combination with cisplatin.01.02.20223Nitric oxide nasal sprayFor treatment of adult high-risk patients with

mild Covid-19 having the risk of progression of

the disease.08.02.20224Vericiguat tablets 2.5mg/ 5mg/ 10mgIndicated to reduce the risk of cardiovascular

death and heart failure (HF) hospitalization

following a hospitalization for heart failure or

need for outpatient IV diuretics, in adults with

symptomatic chronic HF and ejection fraction

less than 45%25.02.20225Inosine pranobex bulk and Inosine pranobex 500mg tabletAs add therapy for the treatment of mild

Covid-19 patients with co-morbidities and

moderate Covid-19 patients, in light of Covid

19 outbreak for restricted emergency use in

the country02.03.20226Desidustat bulk and

Desidustat tablets 25mg and 50mgFor treatment of Anemia in adult patients

with chronic kidney disease (CKD) not on

Dialysis and on Dialysis03.03.2022

The New drugs list 2021 is given below:

S.NO.Name of drugINDICATIONDATE OF ISSUE1.Avanafil bulk and Avanafil tablets

50mg/100mg/200mgFor the treatment of erectile dysfunction26.02.20212.Omidenepag isopropyl ophthalmic solution

0.002% w/vFor the treatment of glaucoma and ocular

hypertension12.03.20213Ozenoxacin bulk and Ozenoxacin cream 1% w/wIndicated for the topical treatment of

impetigo due to staphylococcus aureus or streptococcus pyogenes in adult and

pediatric patients 2 months of age and

older15.04.202142-Deoxy-D-Glucose bulk and 2-Deoxy-D-Glucose 2.34g & 5.85g sachetAs an adjunct therapy only in moderate to

severe Covid-19 patients01.05.20215Capmatinib 150mg and 200mg film-coated

tabletsCapmatinib is a kinase inhibitor indicated

for the treatment of an adult patients with

metastatic non-small cell lung cancer

(NSCLC) whose tumors have a mutation

that leads to mesenchymal-epithelial

transition (MET) exon 14 skipping.12.05.20216Rucaparib camsylate bulk and Rucaparib tablets 200mg/300mgOvarian cancer

• For the maintenance treatment of adult

patients with recurrent epithelial ovarian,

the fallopian tube, or primary peritoneal

cancer who are in a complete or partial

response to platinum-based

chemotherapy.

• For the treatment of adult patients with

a deleterious BRCA mutation (germline

and/or somatic)- associated epithelial

the ovarian, fallopian tube, or primary

peritoneal cancer who have been treated

with two or more chemotherapies. Select

patients for therapy based on an FDA approved companion diagnostic for

RUBRACA.

Prostate cancer

• For the treatment of adult patients with

a deleterious BRCA mutation (germline

and/or somatic) associated metastatic

castration-resistant prostate cancer

(mCRPC) who have been treated with

androgen receptor-directed therapy and a taxane-based chemotherapy.12.05.20217Trientine Tetrahydrochloride bulk and

Trientine Tetrahydrochloride capsules 333 mg (Each capsule contains Trientine

tetrahydrochloride 333mg equivalent to

Trientine 167mg base)For the treatment of Wilson's disease

(hepatolenticular degeneration) in patients

intolerant to Penicillamine. It should be

used when continued treatment with

Penicillamine is no longer possible because

of intolerable or life-endangering side

effects08.06.20218Rucaparib tablets 250mgOvarian cancer

• For the maintenance treatment of adult

patients with recurrent epithelial ovarian,

fallopian tube, or primary peritoneal

cancer who are in a complete or partial

response to platinum-based chemotherapy. • For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated

with two or more chemotherapies. Select

patients for therapy based on an FDAapproved companion diagnostic for

RUBRACA. Prostate cancer • For the treatment of adult patients with a deleterious BRCA mutation (germline

and/or somatic) associated metastatic

castration-resistant prostate cancer

(mCRPC) who have been treated with

androgen receptor-directed therapy and a taxane-based chemotherapy.18.06.20219Vigabatrin bulk and Vigabatrin powder for oral solution 500mgFor the treatment of

1) Refractory Complex Partial Seizures as

adjunctive therapy in patients 2 years of

age and older who have responded

inadequately to several alternative

treatments; Vigabatrin for Oral Solution,

USP, 500 mg is not indicated as a first line agent. 2) Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.18.06.202110Cangrelor tetra sodium bulk and Cangrelor for injection 50mg/vialIndicated as an adjunct to percutaneous

coronary intervention (PCI) to reduce the

risk of periprocedural myocardial infarction (MI), repeat coronary revascularization,

and stent thrombosis (ST) in patients who

have not been treated with a P2Y12

platelet inhibitor and are not being given a

glycoprotein IIb/IIIa inhibitor21.06.202111Rifapentine bulk and FDC of Isoniazid and

Rifapentine (300mg/300mg)Indicated for the treatment of latent

tuberculosis, caused by Mycobacterium

tuberculosis (For use in NTEP only)28.06.202112Lemborexant tablets 5mg/10mgTreatment for insomnia01.07.202113Cetilistat bulk and Cetilistat 120 mg tabletsFor the treatment of Obesity (limited to patients with both type 2 diabetes mellitus and dyslipidemia, and with a BMI ≥ 25 kg/m2 in spite of dietary treatment and /or exercise therapy)09.07.202114Benzonatate bulk and Benzonatate capsules

100mgFor the treatment of refractory cough15.07.202115Cariprazine hydrochloride bulk and Cariprazine capsules 1.5mg/3mg/4.5mg and 6mgFor the treatment of Schizophrenia in

adults. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults16.07.202116Gadoteridol 279.3 mg/ml for injectionFor intravenous use in magnetic

resonance imaging (MRI) in adults and

pediatric patients over 2 years of age for whole-body MRI including the head, neck, liver, breast,  usculoskeletal system and soft tissue pathologies29.07.202117Darolutamide 300mg film-coated tabletsFor the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC)13.08.202118Tetracosactide BP bulk and Tetracosactide

injection BP 250 mcg/mlDiagnostic test for the investigation of

adrenocortical insufficiency13.08.202119Cabozantinib (S) - Malate bulk and Cabozantinib tablets 20mg, 40mg and 60mg(1) For the treatment of patients with

advanced renal cell carcinoma (RCC).

(2) For the treatment of patients with Hepatocellular Carcinoma (HCC) who have been previously treated with sorafenib.10.09.202120Tipiracil hydrochloride bulk and FDC of 1)  Trifluridine 15mg + Tipiracil 6.14mg and 2) Trifluridine 20mg + Tipiracil 8.19mgIndicated for the treatment of

i) adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine, oxaliplatin and

irinotecan-based chemotherapy, an antiVEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy

ii) Adult patients with metastatic gastric or gastroesophageal junction

adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum,

either a taxane or irinotecan, and if

appropriate, HER2/ neu-targeted therapy.16.09.202121Selumetinib 10mg & 25mg capsuleIndicated for the treatment of Pediatric

patients 3 years of age and older with

neurofibromatosis type 1 (NF1) and who

have symptomatic, inoperable plexiform

neurofibromas (PN)17.09.202122Biapenem sterile bulk and Biapenem for injection 300mgComplicated urinary tract infections17.09.202123Tafamidis soft gelatin capsules 61 mgIndicated for the treatment of wild-type or

hereditary transthyretin amyloidosis in

adult patients with cardiomyopathy (ATTRCM)30.11.202124Molnupiravir bulk and Molnupiravir capsules

200mgFor treatment of adult patients with

COVID-19, with SpO2 >93% and who have

high risk of progression of the disease

including hospitalization or death, in light

of Covid 19 outbreak for restricted

emergency use in the country28.12.202125Selexipag bulk and Selexipag tablets…200mcg/ 400mcg/ 600mcg/ 800mcg/ 1000mcg/ 1200mcg/ 1400mcg/ 1600mcgFor the treatment of Pulmonary Arterial Hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH31.12.2021

Also Read: Best cough syrup names in India 2023

CDSCO approved drug list 2021 pdf

The New drugs list 2021 contains Avanafil bulk drug and Avanafil tablets 50mg, 100 mg, and 200 mg. That is used in the treatment of erectile dysfunction in males.

Another new drug in this list is Omidenepag isopropyl ophthalmic solution 0.002%w/v. The drug is indicated for the treatment of glaucoma and ocular hypertension. 

Usually, the whole new drugs list for a year is completed at the end of the year. CDSCO issue new drugs at various time periods in the year. 

RELATED POSTS:

• DPCO LIST 2018
• SCHEDULE G DRUG LIST
• SCHEDULE H1 DRUG LIST
• LATEST DPCO LIST 2020