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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.
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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