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List of Approved Drug for Marketing in India in the
Year 2020

S. NO APPROVED DRUG INDICATION APPROVAL DATE
1.

 Cidofovir dihydrate bulk drug and Cidofovir injection 75 mg/ ml (5 ml single use vial)

Cidofovir is indicated for the treatment of CMV retinitis in adults with acquired immune defeciency syndrome (AIDS) and without renal dysfunction. It should be used only when other medicinal products are considered as unsuitable.

 03.01.2020

2.

Dacomitinib tablet 15mg, 30mg and 45mg

For the first line treatmrnt of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations

03.01.2020

3.

Alpelisib film coated tablets 50mg, 150mg, 200mg

Alpelisib is a kinase inhibitor indicated in combination with Fulvestrant for the treatment of postmenopausal women, and men, with Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

 03.01.2020

4. Isavuconazole sulfate 100mg capsules Indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis 14.02.2020
5. Azelnidipine tablets IP 8 mg For the treatment of Stage I Hypertension 04.03.2020
6. Riboflavin Ophthalmic Solution 0.1% It is intended to treat keratoconus and corneal ecstasia following refractive surgery 11.03.2020
7. Pixantrone 29mg powder for concentrate for solution for infusion Indicated as 3rd line and 4th line therapy for the treatment of adult patients with multiply relapsed or refractory aggresive Non-Hodgkins B- Cell Lymphomas (NHL)

11.03.2020

8. FDC of Bilastine 20mg and Montelukast 10mg tablets Indicated for the treatment of allergic rhinitis in adults. 11.03.2020
9.

Obeticholic acid bulk drug and Obeticholic acid 5mg/10mg tablets

For the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adult with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA

11.03.2020

10. Isavuconazole (as Isavuconazonium sulfate) 200mg powder for concentrate for solution for infusion Indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis 11.03.2020

 

 


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