Made in Its 40 Meeting Held on 09.11.2017 at CDSCO HQ New Delhi

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Made in Its 40 Meeting Held on 09.11.2017 at CDSCO HQ New Delhi

Recommendations of the SEC (Endocrinology & Metabolism) made in its 40thmeeting held on 09.11.2017 at CDSCO HQ New Delhi: Age File no./Drug Name Name of firm/ Recommendations nda Institute no. Subsequent New Drugs Division 1 12-116/2017-DC (Pt- Firm didn’t turn up for the presentation. Zydus-snd) M/s.Zydus Teneligliptin tablet 40mg add strength Biological Division 2 4- M/s.BioGenomi The firm presented the pre-clinical data and 438/BioGenomics/17 cs Ltd. Phase I PK/PD data generated in healthy BD volunteers. Recombinant insulin After detailed deliberation committee aspart observed that the request of the firm for Phase III clinical trial waiver cannot be considered. The committee recommended that the firm should submit Phase III clinical trial protocol for review. 3 4-42/Biocon/PAC-R- M/s. Biocon The firm presented their proposal for Insulin Glargine/17- Limited. approval for extension of age group in the BD already approved indication to “2 years and Insulin Glargine above” from “6 years and above”. After detailed deliberation, the committee recommended for approval of the proposed change. 4 4-436/Novo M/s. Novo The firm was not in position to present their Nordisk/17BD Nordisk India proposal so the case was deferred. Fast acting insulin Pvt. Ltd aspart 5 4- M/s. Novo The firm presented the supportive data 83/NovoNordisk/PAC Nordisk India including clinical data for the proposed -R-Liraglutide/17-BD Pvt. Ltd. expansion of the indication. Liraglutide Injection The committee after detailed deliberation, recommended that the indication may be expanded as follows: “To reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes mellitus and established cardiovascular disease”. 6 4-76/Novo M/s. Novo The firm presented the supportive data for Nordisk/PAC-R- Nordisk India updating the package insert. Insulin Degludec/17- Pvt. Ltd. After detailed deliberation, the committee BD recommended for approval of the proposed Insulin Degludec update in the package insert. (Tresiba) 40thSEC (Endocrinology & Metabolism)_09.11.2017 .

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(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date , , ,, , 3 June 2011 (03.06.2011) 201 1/064352 Al (51) International Patent Classification: (74) Agents: HAMMANN, Heinz et al; Boehringer Ingel A61K 31/155 (2006.01) A61K 31/519 (2006.01) heim GmbH, Corporate Patents, Binger Str. 173, 55216 A61K 31/44 (2006.01) A61K 45/06 (2006.01) Ingelheim am Rhein (DE). (21) International Application Number: (81) Designated States (unless otherwise indicated, for every PCT/EP20 10/068349 kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (22) International Filing Date: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, 26 November 2010 (26.1 1.2010) DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (25) Filing Language: English HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (26) Publication Language: English ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (30) Priority Data: NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, 09177418.2 27 November 2009 (27.1 1.2009) EP SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, 10166714.5 2 1 June 2010 (21 .06.2010) EP TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (71) Applicant (for all designated States except US): (84) Designated States (unless otherwise indicated, for every BOEHRINGER INGELHEIM INTERNATIONAL kind of regional protection available): ARIPO (BW, GH, GMBH [DE/DE]; Binger Str.
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