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 2022Â 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)Â 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.
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