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Recommendations of the SEC (Cardiovascular & Renal) made in its 71st meeting held on 06.12.2019 at CDSCO HQ New Delhi:

Agenda File Name & Drug Name, Strength Firm Name Recommendations No Introductory remarks SND Division

12-35/2019-DC (Pt-Misc-SND) M/s Boehnigher The firm presented the Dabigatran etexilate mesilate capsule Ingelheim proposal to update the 75mg/110mg/150mg package insert before the committee of the drug Dabigatran etexilate mesilate 1 capsule75mg/110mg/150mg. After detailed deliberation, the committee recommended for approval of the updated package insert. FDC Division FDC/MA/19/000044 M/s. Akums In light of the earlier Kamedoxomil eq. to Drugs & recommendation dated Azilsartan Medoxomil + Chlorthalidone Pharmaceuticals 07.05.2019, firm presented IP + Cilnidipine IP Ltd. the changes made in the protocol. However, the committee noted that the 2 proposed changes are not explicitly clear. The committee recommended that the firm should present the complete Clinical trial protocol in the next meeting. FDC/MA/19/000105 M/s. Akums In light of the earlier Benidipine Drugs & recommendation dated Hydrochloride+Chlorthalidone IP Pharmaceuticals 07.06.2019, firm presented 3 (4mg/4mg + 6.25mg/12.5mg) Film Ltd. the revised CT Protocol. The coated tablet committee noted that the firm has revised and submitted the CT protocol yesterday only and hence could not be reviewed by the committee. The committee recommended that the firm should present their revised protocol during the next meeting. FDC/MA/18/000065 M/s. Akums In light of the earlier Benidipine Hydrochloride + Metoprolol Drugs & recommendation of the 4 Succinate IP eq. to Metoprolol tartrate Pharmaceuticals committee dated 12.02.2019, (4mg+23.75mg eq. to 25mg & Ltd. the firm presented the BE 4mg+47.50mg eq. to 50mg) tablets study report. After detailed deliberation, the committee recommended

71st th SEC (Cardiovascular & Renal) _06.12.2019 Agenda File Name & Drug Name, Strength Firm Name Recommendations No that the firm may initiate the clinical trial for which CT NOC has already been issued to the firm. 4-146/2007-DC In light of recommendation Atenolol++Hydrochlorothiazide of committee dated 27.11.2019, the firm 5 presented justification for the FDC. After detailed deliberation, M/s. Sun the committee recommended Pharma for continued manufacturing and marketing of the FDC subject to the condition that it should be indicated for stage-II hypertension with co-morbidities like CAD and Post MI. GCT Division 6 CT/51/19 Klinera Applicant presented their Solensertib proposal along with study protocol before the committee. Assessment of risk versus benefit to the patients- The safety profile of the study drug from various preclinical toxicology studies and clinical studies justify the conduct of the trial. Innovation vis-a-vis existing therapeutic- To evaluating the efficacy and safety of selonsertib in subjects with moderate to Advanced Diabetic Kidney Disease. Unmet medical need in the country- To develop alternative, safe and efficacious treatment in moderate to Advanced Diabetic Kidney Disease.

After detailed deliberation, the committee recommended for grant of permission to conduct the study subject to condition that applicant should provide guidelines to the investigators to decide

71st th SEC (Cardiovascular & Renal) _06.12.2019 Agenda File Name & Drug Name, Strength Firm Name Recommendations No exclusion of patients with non-diabetic kidney disease. CT/87/19 Novartis Applicant presented their LCZ696 proposal for open label extension study along with study protocol before the committee. Assessment of risk versus benefit to the patients- The safety profile of the study drug from various preclinical toxicology studies and clinical studies justify the 7 conduct of the trial. Innovation vis-a-vis existing therapeutic- to evaluate long-term safety and tolerability of open label sacubitril/ in pediatric patients with due to systemic left ventricle systolic dysfunction. Unmet medical need in the country- To develop alternative, safe and efficacious treatment in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction. After detailed deliberation, the committee recommended for grant of permission to conduct the study. Medical Device Division In light of earlier recommendations dated 8 07.11.2019, the firm presented the proposal to import and market Hydra Transcatheter Aortic Valve M/s Vascular 4-MD/CT-132/2017-DC & with their justification. Concepts Ltd., IMP/MD/2019/10487 The committee after detailed Bangalore- Hydra Transcatheter Aortic Valve deliberation recommended 560024 that the firm should submit the details of causality analysis of the death cases in the clinical trial along with status of the product in other countries.

71st th SEC (Cardiovascular & Renal) _06.12.2019 Agenda File Name & Drug Name, Strength Firm Name Recommendations No The committee shall review the mortality data along with the analysis of death cases already done by CDSCO. 4-MD/CT-241/2019-DC M/s. Batra The applicant presented the Supraflex and Xience family drug Hospital and proposal as investigator eluting Stent Medical initiated study. Research The Supraflex and Xience Centre family drug eluting Stent are already approved and marketed in India. 9 The committee recommended that there may not be any objection for the study as per the protocol presented. Since, there is no specific provisions regarding investigator initiated study, the CDSCO may take action as per the regulatory provisions based on clarification from the applicant whether, it is academic clinical trial or otherwise. New Drugs Division The Committee noted that M/s Sanofi, the innovator of the product had already submitted that they are no longer importing and marketing the drug in the 12-01/12-DC (Pt-9 Dronedarone) Internal 10 country due to low Dronedarone Discussion commercial interest and declined shares. The committee recommended that the same may be intimated to the State Drugs Controllers. The Committee deliberated 12-01/12-DC (Pt-9 ) Internal the matter and recommended 11 Everolimus Discussion for continued marketing of the drug. The Committee noted that there is hardly any clinical use of this drug in the 12-01/12-DC (Pt-9 ) Internal country. However, CDSCO Aliskiren Discussion may collect further 12 information with regard to updated safety and regulatory status of the drug

71st th SEC (Cardiovascular & Renal) _06.12.2019 Agenda File Name & Drug Name, Strength Firm Name Recommendations No in other countries from the innovator and other sources.

The Committee after detailed 12-01/12-DC (Pt-9 ) Internal deliberation recommended 13 Ambrisentan Discussion for continued marketing of the drug. The Committee after detailed deliberation recommended that the drug may be allowed to be sold through retail 12-01/19-DC (Pt-235) Internal 14 pharmacies. Tolvaptan Discussion However, the drug should be sold by retail only under the prescription of Medical specialists. The committee after detailed deliberation opined that the 12-01/19-DC(Pt-53) Dabigatran adverse drug reaction is Dabigatran SAE Report already reported and known. 15 Therefore, it does not merit any further action. Already covered under 12-01/19-DC(PU-010) Package insert 16 agenda number 1. Dabigatran Etexilate updation

71st th SEC (Cardiovascular & Renal) _06.12.2019