The Central Drugs Standard Control Organization (CDSCO) every year approved new drugs and publish the list of new drugs approved in the year. Every year new types of drugs get approved by the CDSCO to help win against different new diseases. We have shared the list of drugs that are approved this year till date.

List of new drugs approved in the year 2021
List of new drugs approved in the year 2021

Avanafil

Name of the drug: Avanafil bulk and Avanafil tablets 50mg/100mg/200mg

Issue Date: 26.02.2021

Indication: Avanafil has been approved for the treatment of erectile dysfunction.

Omidenepag isopropyl

Name of the drug: Omidenepag isopropyl ophthalmic solution 0.002% w/v

Issue Date: 12.03.2021

Indication: Omidenepag isopropyl ophthalmic solution has been approved for the treatment of glaucoma and ocular hypertension.

Ozenoxacin

Name of the drug: Ozenoxacin bulk and Ozenoxacin cream 1% w/w

Issue Date: 15.04.2021

Indication: Ozenoxacin has been approved for the treatment of impetigo due to staphylococcus aureus or streptococcus pyrogenes in adult and
pediatric patients 2 months of age and older.

2-Deoxy-D-Glucose

Name of the drug: 2-Deoxy-D-Glucose bulk and 2-Deoxy-D-Glucose 2.34g & 5.85g sachet

Issue Date: 01.05.2021

Indication: 2-Deoxy-D-Glucose has been approved by the CDSCO for the treatment of adjunct therapy only in moderate to severe Covid-19 patients.

Capmatinib

Name of the drug: Capmatinib 150mg and 200mg film-coated tablets

Issue Date: 12.05.2021

Indication: Capmatinib is one type of kinase inhibitor that has been approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping.

Rucaparib camsylate

Name of the drugs: Rucaparib camsylate bulk and Rucaparib tablets 200mg/300mg

Issue Date: 12.05.2021

Indication:

  • For the maintenance treatment of adult patients with recurrent epithelial ovarian, the fallopian tube, or primary peritoneal cancer who are in 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 FDAapproved companion diagnostic for RUBRACA
  • 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 taxane-based chemotherapy.

Trientine Tetrahydrochloride

Name of the drug: Trientine Tetrahydrochloride bulk and Trientine Tetrahydrochloride capsules 333 mg (Each capsule contains Trientine
tetrahydrochloride 333mg equivalent to Trientine 167mg base)

Issue Date: 08.06.2021

Indication: This drug has been approved for the treatment of Wilson’s disease

Rucaparib

Name of the Drug: Rucaparib tablets 250mg

Issue Date: 18.06.2021

Indication:

  • 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 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 metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy

Vigabatrin

Name of the Drug: Vigabatrin bulk and Vigabatrin powder for oral solution 500mg

Issue Date: 18.06.2021

Indication:

  • Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternatives treatments; Vigabatrin for Oral Solution, USP, 500 mg is not indicated as a first-line agent.
  • Infantile Spasms – monotherapy in infants 1 month to 2 years of age for whom

Cangrelor tetra sodium

Name of the Drug: Cangrelor tetrasodium bulk and Cangrelor for injection 50mg/vial

Issue Date: 21.06.2021

Indication: Indicated 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 inhibitor

Rifapentine

Name of the Drug: Rifapentine bulk and FDC of Isoniazid and Rifapentine (300mg/300mg)

Issue Date: 28.06.2021

Indication: Indicated for the treatment of latent tuberculosis, caused by Mycobacterium tuberculosis (For use in NTEP only)

Lemborexant

Issue Date: 01.07.2021

Indication: Used in the Treatment for insomnia

Cetilistat

Name of the Drug: Cetilistat bulk and Cetilistat 120 mg tablets

Issue Date: 09.07.2021

Indication: For the treatment of Obesity (limited to patients with both type 2 diabetes mellitus and dyslipidaemia, and with a BMI ≥ 25 kg/m2 in spite of dietary treatment and /or exercise therapy)

Benzonatate

Name of the Drug: Benzonatate bulk and Benzonatate capsules 100mg

Issue Date: 15.07.2021

Indication: Used For the treatment of refractory cough

Cariprazine Hydrochloride

Name of the Drug: Cariprazine hydrochloride bulk and Cariprazine capsules 1.5mg/3mg/4.5mg and 6mg

Issue Date: 16.07.2021

Indication: For the treatment of Schizophrenia in adults. Acute treatment of manic or mixed episodes associated with bipolar I disorder
in adult

Gadoteridol

Name of the Drug: Gadoteridol 279.3 mg/ml for injection

Issue Date: 29.07.2021

Indication: For 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, musculoskeletal system and soft tissue pathologies.

Darolutamide

Name of the Drug: Darolutamide 300mg film-coated tablets

Issue Date: 13.08.2021

Indication: For the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC)

Tetracosactide BP

Name of the Drug: Tetracosactide BP bulk and Tetracosactide injection BP 250 mcg/ml

Issue Date: 13.08.2021

Indication: Diagnostic test for the investigation of adrenocortical insufficiency

Cabozantinib (S) – Maleate

Name of the Drug: Cabozantinib (S) – Maleate bulk and Cabozantinib tablets 20mg, 40mg and 60mg

Issue Date: 10.09.2021

Indication:

  • For the treatment of patients with advanced renal cell carcinoma (RCC).
  • For the treatment of patients with Hepatocellular Carcinoma (HCC) who have been previously treated with sorafenib.

Tipiracil hydrochloride

Name of the Drug: Tipiracil hydrochloride bulk and FDC of 1) Trifluridine 15mg + Tipiracil 6.14mg and 2) Trifluridine 20mg + Tipiracil 8.19mg

Issue Date: 16.09.2021

Indication:

  • Adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild type, an anti-EGFR therapy
  • Adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a block of platinum, either a taxane or irinotecan and if appropriate, HER2/ neu-targeted therapy.

Selumetinib

Name of the Drug: Selumetinib 10mg & 25mg capsule

Issue Date: 17.09.2021

Indication: Indicated 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)

Biapenem

Name of the Drug: Biapenem sterile bulk and Biapenem for injection 300mg

Issue Date: 17.09.2021

Indication: Complicated urinary tract infections

Source of the Information: The information provided here is collected from the official website of CDSCO, Government of India. Click here to visit the source file.

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