The Central Drugs Standard Control Organization (CDSCO), India, has approved four drugs in the month of September 20172. Two of the approved drugs belong to Oncology & Haematology (Ribociclib and Treosulfan), one from Neurology and Psychiatry (Brivaracetam) and one from Reproductive & Urology (Dienogest) subject expert committee. The details of these four drugs are described –

  1. Briveracetam film coated tablets: On September 07, 2017 CDSCO has approved Briveracetam film coated tablets in the strengths of 50 mg, 75 mg and 100 mg; indicated as an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in patients 16 years of age and older with epilepsy.

    The import and marketing approval of Brivaracetam 50mg, 75 mg &100mg film-coated tablets has been granted to UCB India Pvt. Ltd. based on the global clinical study report including data generated from various clinical studies conducted on 256 Indian patients on tablet formulations. The Subject Expert Committee (ESC) of CDSCO observed that the data from the Indian subset analysis is in line with the global data3.
  2. Treosulfan Bulk & injection 5g/vial: On September 26, 2017, CDSCO has approved Treosulfan Bulk & injection 5g/vial for the conditioning treatment prior to haematopoetic stem-cell transplantation.

    The manufacturing and marketing approval of Treosulfan Bulk & injection 5g/vial has been granted to Emcure Pharmaceutical Ltd. The approval is subject to the condition that the firm shall conduct phase IV clinical trial in 50 patients. Accordingly, the firm shall submit phase IV protocol within 3 months of grant of manufacture and marketing permission4.
  3. Ribociclib 200 mg film coated tablets: On September 27,2017 CDSCO has approved Ribociclib 200 mg film coated tablets in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of post menopausal women with the hormone receptor (HR)-Positive, human epidermal growth factor receptor 2 (HER2)-Negative advanced or metastatic breast cancer.

    The import and market approval of Ribociclib 200 mg film coated tablets has been granted to Sandoz Pvt. Ltd. The approval is subject to the condition that the firm shall submit the report of ongoing global clinical trials where India is one of the participating countries5.
  4. Dienogest Bulk & 2mg Tablet: On September 28 2017, CDSCO has approved Dienogest Bulk & 2mg Tablet for the management of Pelvic pain associated with Endometriosis.

Footnotes

2. http://www.cdsco.nic.in/forms/list.aspx?lid=2034&Id=11

3. http://www.cdsco.nic.in/writereaddata/Recommendation17_3_2017.pdf

4. http://www.cdsco.nic.in/writereaddata/Recommendation%20Oncology_16_05_17.pdf

5. http://www.cdsco.nic.in/writereaddata/Recommendation%20Oncology_16_05_17.pdf

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