List Of CDSCO Approved Drugs 2021

To date, here is a list of new drugs that have been approved in the year 2021.

1.Avanafil bulk and Avanafil tablets 50mg/100mg/200mg:

Erectile dysfunction (ED) treatment

2.Omidenepag isopropyl ophthalmic solution 0.002% w/v:

Glaucoma and ocular hypertension are treated with this medication.

3.Ozenoxacin bulk and Ozenoxacin cream 1% w/w:

Indicated in adults and children aged 2 months and up for the treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes.

4. 2-Deoxy-D-Glucose bulk and 2-Deoxy-D-Glucose 2.34g & 5.85g sachet:

Only in moderate to severe cases as adjunct therapy Patients with Covid-19

5. Capmatinib 150mg and 200mg film-coated tablets:

Capmatinib is a kinase inhibitor used to treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that causes exon 14 skipping in the mesenchymal-epithelial transition (MET) gene.

6. Rucaparib camsylate bulk and Rucaparib tablets 200mg/300mg:

• Adult patients with a recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy should receive maintenance treatment.

• For the treatment of adult patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received two or more chemotherapies and have a deleterious BRCA mutation (germline and/or somatic). Choose patients for treatment based on an FDA-approved RUBRACA companion diagnostic.

• For the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and taxane-based chemotherapy and have a deleterious BRCA mutation (germline and/or somatic).

7. Trientine Tetrahydrochloride bulk and Trientine Tetrahydrochloride capsules 333 mg (Each capsule contains Trientine tetrahydrochloride 333mg equivalent to Trientine 167mg base):

In patients who are intolerant to Penicillamine, for the treatment of Wilson's disease (hepatolenticular degeneration). It should be used when continuing Penicillamine treatment is no longer possible due to intolerable or life-threatening side effects.

8.Rucaparib tablets 250mg:

• Adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy should receive maintenance treatment.

9. Vigabatrin bulk and Vigabatrin powder for oral solution 500mg:

Vigabatrin for Oral Solution, USP, 500 mg is not indicated as a first-line agent for the treatment of

1) Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have not responded adequately to several alternative treatments.

2) Infantile Spasms - monotherapy in infants aged one month to two years old whose potential benefits outweigh the risk of vision loss.

10.Cangrelor tetra sodium bulk and Cangrelor for injection 50mg/vial:

In patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor, this drug is used as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST).

11.Rifapentine bulk and FDC of Isoniazid and Rifapntine (300mg/300mg):

It's used to treat Mycobacterium tuberculosis-caused latent tuberculosis (For use in NTEP only)

12.Lemborexant tablets 5mg/10mg:

Insomnia treatment

13.Cetilistat bulk and Cetilistat 120 mg tablets:

Obesity treatment (limited to patients with type 2 diabetes mellitus and dyslipidemia, and with a BMI of 25 kg/m2 despite dietary and/or exercise therapy)

14.Benzonatate bulk and Benzonatate capsules100mg:

Treatment of Refractory cough

15.Cariprazine hydrochloride bulk and Cariprazine capsules 1.5mg/3mg/4.5mg and 6mg:

For the treatment of adult Schizophrenia. Adults with bipolar I disorder receive acute treatment for manic or mixed episodes.

16.Gadoteridol 279.3 mg/ml for injection:

For intravenous use in magnetic resonance imaging (MRI) in adults and pediatric patients over the age of 2 years for whole-body MRI including the head, neck, liver, breast, musculoskeletal system, and soft tissue pathologies in adults and pediatric patients over the age of 2 years.

17.Darolutamide 300mg film-coated tablets:

Patients with nonmetastatic castration-resistant prostate cancer may benefit from this treatment (nmCRPC)

18. Tetracosactide BP bulk and Tetracosactide injection BP 250 mcg/ml:

A diagnostic test to look into adrenocortical insufficiency.

19.Cabozantinib (S) - Malate bulk and Cabozantinib tablets 20mg, 40mg and 60mg:

(1) For the treatment of advanced renal cell carcinoma patients (RCC).

(2) For the treatment of patients with Hepatocellular Carcinoma (HCC) who have previously received sorafenib.

20. Tipiracil hydrochloride bulk and FDC of

1)Trifluridine 15mg + Tipiracil 6.14mg and

2)Trifluridine 20mg + Tipiracil 8.19mg:

i)Adult patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an antiVEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy are candidates for this treatment.

ii) Adults with metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received at least two lines of chemotherapy, including a fluoropyrimidine, platinum, either a taxane or irinotecan and, if appropriate, HER2/neu-targeted therapy.

21.Selumetinib 10mg & 25mg capsule:

Indicated for the treatment of neurofibromatosis type 1 (NF1) patients aged 3 years and older who have symptomatic, inoperable plexiform neurofibromas (PN).

22. Biapenem sterile bulk and Biapenem for injection 300mg:

Complicated urinary tract infections

23. Tafamidis soft gelatin capsules 61 mg:

Adult patients with cardiomyopathy who have wild-type or hereditary transthyretin amyloidosis should be treated with this medication (ATTRCM).

24.Molnupiravir bulk and Molnupiravir capsules 200mg:

In light of the COVID-19 outbreak, for treatment of adult COVID-19 patients with SpO2 >93% and a high risk of disease progression, including hospitalization or death, for limited emergency use in the country.

25.Selexipag bulk and Selexipag tablets…200mcg/400mcg/ 600mcg/ 800mcg/ 1000mcg/ 1200mcg/1400mcg/ 1600mcg:

To delay disease progression and reduce the risk of PAH hospitalisation in patients with pulmonary arterial hypertension (PAH, WHO Group I).