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Recommendations of the SEC (Cardiovascular & Renal) made in its 74th meeting held on 04.03.2020 at CDSCO, HQ New Delhi:

Agenda File Name & Drug Name, Firm’s Name No Strength Recommendation New Drugs Division As per recommendation of the Technical Committee and SEC, the firm was granted permission to conduct the BE study on 15.04.2019.

The firm presented the results of the 12-21/16-DC M/s Emcure BE study before the committee. 1. Succroferric Oxyhydroxide Pharmaceuticals

chewable tablet 500mg Limited After detailed deliberation, committee recommended for grant of permission for manufacture and marketing of Succroferric Oxyhydroxide chewable tablet 500mg. Subsequent New Drugs Division The firm presented the reports of bioequivalence study. SND/MA/19/000120 M/s Synokem After detailed deliberation the 2. Ivabradine Prolonged release Pharmaceuticals committee recommended for the tablet 10mg & 15mg Ltd initiation of the proposed Phase III . FDC Division FDC/IMP/19/000061 M/s. Fresenius In light of the earlier Glucose Monohydrate E.P Medical Care India recommendation of the committee 1.100gm+ Chloride Pvt. Ltd. dated 06.02.2020, the firm presented Hexahydrate E.P their proposal before the committee. 0.1.17gm+Calcium Chloride The committee noted that the product Dihydrate E.P. is approved in more than 40 3. 0.2205gm+Sodium Hydrogen countries including UK, Australia E.P . etc. 2.940gm+Sodium Chloride E.P. After detailed deliberation the 6.136gm solution for committee recommended for the haemodialysis/haemofiltration grant of permission for Import and (multi Bic Potassium free) Marketing of the product. FDC/IMP/19/000062 M/s. Fresenius In light of the earlier For 2mmol/l Potassium Medical Care India recommendation of the committee Chloride E.P. 01491gm+Sodium Pvt. Ltd. dated 06.02.2020, the firm presented Chloride E.P. 6.136gm+Sodium their proposal before the committee. Hydrogen Carbonate E.P. The committee noted that the product 2.940gm+Calcium Chloride is approved in more than 40 4. Dihydrate E.P. countries including UK, Australia 0.2205gm+Magnesium Chloride etc. Hexahydrate E.P. After detailed deliberation the 0.1017gm+Glucose committee recommended for the Monohydrate E.P. 1.100gm grant of permission for Import and For 4 mmol/l Potassium Marketing of the product.

74th SEC (Cardiovascular & Renal) _04.03.2020 Agenda File Name & Drug Name, Firm’s Name No Strength Recommendation Chloride E.P. 0.2982gm+Sodium Chloride E.P. 6.136gm+Sodium Hydrogen Carbonate E.P. 2.940gm+Calcium Chloride Dihydrate E.P. 0.2205gm+Magnesium Chloride Hexahydrate E.P. 0.1017gm+Glucose Monohydrate E.P. 1.100gm solution for haemodialysis/haemofiltration 4-24/2018-DC (Pt. Synokem) M/s. Synokem Firm presented BE/CT report before Azilsartan Kamedoxomil eq. to the committee. After detailed Azilsartan Medoxomil deliberation, the committee 5. 40mg/40mg + Cilnidipine recommended for grant of 5mg/10mg film coated bilayered permission for manufacturing and tablet marketing of the proposed FDC. FDC/MA/19/000157 M/s. Synokem Firm presented BE/CT protocol Fimasartan potassium trihydrate before the committee. After detailed Eq. to Fimasartan potassium deliberation, the committee 60mg/60mg + Cilnidipine IP recommended for grant of 5mg/10mg film coated tablet permission to conduct the BE study subject to the condition that one 6. General physician with MD (Medicine) should be part of the study team. The committee also recommended for grant of permission to conduct the proposed Phase III Clinical Trial. FDC/MA/19/000135 M/s. Archimedis The firm presented their proposal Ivabradine HCl eq. to Healthcare Pvt. along with protocol for BE study Ivabradine+ Metoprolol Tartrate Ltd. before the committee with Phase III (7.5mg/5.0mg/5.0mg/7.5mg+25 Clinical Trial waiver. mg/50mg/25mg/50mg) tablet The committee noted that the proposed FDC is approved in EU for the Symptomatic treatment of chronic stable angina pectoris as substitution therapy in adult patients with normal sinus rhythm already controlled by metoprolol and 7. Ivabradine taken concomitantly at the same dose level. After detailed deliberation the committee recommended for grant of permission to conduct the BE study subject to condition that one General physician with MD (Medicine) should be part of the study team. Based on the BE study results the approval of the FDC may be considered for the same indication as approved in EU subject to Phase IV

74th SEC (Cardiovascular & Renal) _04.03.2020 Agenda File Name & Drug Name, Firm’s Name No Strength Recommendation trial.

FDC/MA/19/000159 M/s. Pure & Cure Firm presented their proposal for Atorvastatin Calcium IP Eq. to Healthcare Pvt. conducting the BE study on the Atorvastatin 10mg/20mg + Ltd. proposed FDC. The committee noted Bisulphate IP Eq. to that the FDC is already approved in Clopidogrel 75mg/75mg tablet capsule form. 8. After detailed deliberation, the committee recommended for grant of permission to conduct the BE study. The results of the study shall be presented before the committee for further consideration. FDC/MA/20/000005 M/s. Intas The firm presented their proposal for Combikit of 14 Pharmaceuticals manufacture and marketing of Tablets 90mg Ltd. combikit of 14 Ticagrelor Tablets Each film coated tablet contains: 90mg + 7 Gastro-resistant Ticagrelor IP 90mg + 7 tablets IP 75mg before the Aspirin Gastro-resistant tablets committee. IP 75mg Each enteric coated After detailed deliberation, the tablet contains: Aspirin IP 75mg committee recommended for grant of permission to manufacture and market the proposed combikit for the 9. prevention of thrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with acute coronary syndromes (ACS) including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG) where both Ticagrelor and Aspirin are required. GCT Division CT/96/19 M/s. Medpace The firm presented their proposal Lumasiran along with the Phase III protocol before the committee Assessment of Risk vs. Benefit to the patients- The safety profile of the study drug from preclinical and clinical studies justify the conduct of the trial. Innovation vis-à-vis Existing 10. Therapeutic Option- Cohort A:To evaluate the effect of lumasiran on plasma in patients who are not on dialysis Therapy. Cohort B:To evaluate the effect of lumasiran on plasma oxalate levels in patients who are on dialysis therapy. Unmet Medical Need in the

74th SEC (Cardiovascular & Renal) _04.03.2020 Agenda File Name & Drug Name, Firm’s Name No Strength Recommendation country- The test drug may potentially provide alternate treatment option in patients with Advanced Primary Type 1 (PH1). After detailed deliberation the committee recommended for grant of permission to conduct the study subject to condition that frequency and type of dialyzer used in dialysis group should be uniform across the sites. CT/14/20 M/s. Novartis The firm presented their proposal for Secukinumab Phase III global trial before the committee. After detailed deliberation the committee 11. recommended for grant of permission to conduct the study. It is advised to include some government hospital as study sites. CT/17/20 M/s. Novartis The firm presented their proposal for TQJ230 Phase III global trial before the committee. Assessment of risk vs. Benefit to the patients: The safety profile of the study drugs from preclinical toxicology studies including repeat dose toxicity, Phase-I & II clinical study justify the conduct of the trial. Innovation vis-à-vis Existing Therapeutic option: The Purpose of the study is to assessing the impact of 12. lipoprotein (a) lowering with TQJ230 on major cardiovascular events in patients with established cardiovascular disease. Unmet Medical need in the country: The test drug may potentially provide treatment in patients with established cardiovascular disease. After detailed deliberation the committee recommended for grant of permission to conduct the study. CT/15/20 M/s. George The firm presented their proposal VIS649 Clinical along with the Phase II protocol before the committee Risk versus benefit to the patients- 13. The safety profile of the study drug from preclinical and clinical studies justify the conduct of the trial. Innovation vis-a-vis existing

74th SEC (Cardiovascular & Renal) _04.03.2020 Agenda File Name & Drug Name, Firm’s Name No Strength Recommendation therapeutic- To Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy.

Unmet medical need in the country- The test drug used for treatment with Immunoglobulin A (IgA) Nephropathy an unmet medical need.

After detailed deliberation the committee recommended for grant of permission to conduct the study subject to condition that “IgAN with minimal change disease” should be excluded from the exclusion criteria globally. Medical Device Division

IMP/MD/2019/17070 M/s B L The committee opined that the COR-KNOT® Lifesciences Pvt. proposal should be deliberated in Ltd., presence of cardiac surgeon. Since 14. the invited surgeons could not attend the meeting, the proposal should be deliberated in next meeting along with surgeons. IMP/MD/2019/12154 M/s St. Jude In light of earlier recommendations Clip Delivery System, Steerable Medical India Pvt. of the SEC dated 22.10.2019, the Guide Catheter Ltd., firm presented their justification including the safety, performance data as well post marketing data of the applied product from other countries where the product is marketed. The product is already approved and marketed in many countries 15. including US, Canada, Australia, EU, etc. After detailed deliberation the committee recommended for grant of import & marketing permission for the said device with condition that the firm shall generate systematic PMS data for all cases in the initial two years which will be submitted for review.

74th SEC (Cardiovascular & Renal) _04.03.2020