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1. Recommendations of the Ndac (Reproductive and Urology) Held on 31.03.2012

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1. RECOMMENDATIONS OF THE NDAC (REPRODUCTIVE AND UROLOGY) HELD ON 31.03.2012:- The NDAC (Reproductive and Urology) deliberated the proposals on 31.03.2012 and recommended the following:- AGENDA NAME OF DRUG RECOMMENDATIONS NO. New Drug Committee opined that a phase 3 clinical trial Estradiol 1mg should be conducted on 200 subjects at 4 sites + 1 geographically distributed in the country. Drosperinone Protocol for the study should be submitted 2mg which will be placed before the committee for evaluation. Committee recommended for giving permission to conduct the proposed clinical trial subject to the following conditions:- i) The study should be conducted on 200 subjects in at least 4 centers geographically distributed in the country. 50 % of the trial sites should be multispecialty hospitals. Fesoterodine ii) Urodynamic study should be conducted for 2 Fumarate 4mg all patients. & 8mg Committee also recommended for giving permission to conduct the proposed bioequivalence study. After completion of the above studies, the reports should be placed before the committee for consideration of approval of the drug in the country. Firm had requested for waiver of clinical trial. Committee recommended that a randomised, comparative clinical trial of ulipristal vs levonorgestrel on 200 subjects should be conducted at sites where there is less awareness about emergency contraceptive. Ulipristal 3 Accordingly protocol etc should be submitted Acetate 30mg to DCG(I) for his consideration and giving approval for the study. However committee recommended for giving permission to conduct the proposed bioequivalence study. After completion of the above studies, the reports should be placed before the committee for consideration of approval of the drug in the country. Committee recommended that clinical trial protocol can be approved subject to the following conditions: i) Number of subjects should be at least 200. ii) Sites should be geographically distributed in the country. However before giving final permission by 4 Dienogest 2mg DCG(I) for the clinical trial, subacute toxicity data generated with the source bulk drug should be submitted to DCG(I) for his consideration. Committee also recommended that bioequivalence study should be conducted. Protocol etc. for the same should be submitted to DCG(I) for his consideration. Experts recommended that clinical trial is required to be conducted on 100 subjects. 5 Fesoterodine Accordingly protocol etc should be submitted to DCGI for approval. Recommended for giving permission to conduct the proposed study at the proposed two sites viz. Dr. Suneeta Mittal, AIIMS and 6 Mifepristone Dr. Lakhbir Dhaliwal, PGIMER. Dr. Suneeta Mittal and Dr. Lakhbir Dhaliwal did not participate in the decision making process of this proposal. 7 Metformin Recommended for approval of the study. Published data supporting the use of 30mg/day of centchroman have been submitted by the applicant. Committee recommended for approval of the study subject to the following conditions:- i) Patients with oligomenorrhoea/irregular 8 bleeding/ovarian cysts should be excluded Centchroman from the study. ii) Pelvic ultrasound should be conducted at 3 months and 6 months of follow up. iii) Informed Consent Form as per Appendix V and Investigator Undertaking as per Appendix VII of Schedule Y should be submitted to the office of DCG(I). Recommended for approval of the study subject to the condition that undertaking from the remaining two investigators should be Ferrous 9 submitted to DCG(I). Sucrose Before initiating the study, approval from Ethics Committee should be taken from the same area where the site is located. Global Clinical Trial Committee opined that use of placebo in patients with BPH for four weeks may not affect the patient‟s condition. Committee recommended for giving permission S-equol(AUS- to conduct the study subject to the following 10 131) conditions:- i) The rescue strategy for patients in placebo group should be specified in the protocol. ii) Upper age limit of subjects to be included in the study should be 70 years. Recommended for approval of the study subject to condition that upper age limit of 11 Fesoterodine subjects to be included in the study should be 70 years. Firm has withdrawn the proposal due to 12 Fesoterodine completion of global enrolment. Recommended for approval of the study subject to the following conditions:- i) Subjects aged ≥18 and ≤ 40 years should be 13 SH T006581D included in the study. ii) Undertakings from Investigators should be submitted to DCG(I). 2. RECOMMENDATIONS OF THE NDAC (REPRODUCTIVE & UROLOGY) HELD ON 30.10.2012:- The NDAC (Reproductive & Urology) deliberated the proposals on 30.10.2012 and recommended the following: AGENDA NAME OF DRUG RECOMMENDATIONS NO. Committee recommended for approval of the 1 Gabapentin study. Committee recommended for approval of the 2. Nuva Ring study. Committee recommended for approval of the 3. Ormeloxifene study. Phase III clinical trial was permitted at 04 study centres in 240 subjects. However the report of the trial is submitted on 120 subjects from 03 4. centres. Committee recommended that the firm Carbetocin should complete the trial in 240 subjects and submit the report to the committee for examination. Committee recommended for approval of the 5. DHEA study. Committee recommended for approval of the 6. Metformin versus study. insulin 7. Deferred for the next meeting. Tadalafil Tablets The proposed indication is approved by US- Botulinum toxin Type A FDA. Committee recommended for giving permission to market 200 unit vials of Botulinum toxin Type A subject to condition that the firm should conduct a multicentric, 8. Phase IV clinical trial on 250 patients within a period of 01 year. The protocol etc of the study should be submitted to the DCG(I) for approval within 02 months of approval of the product. 9. Progesterone SR Deferred for the next meeting Vaginal Tablets 10. Sildenafil citrate Orally Deferred for the next meeting Disintegrating Strips 11 Deferred for the next meeting Alfuzocin + Tadalafil There is no data on safety and efficacy of Clotrimazole + lactic Clotrimazole alone in spray form. Therefore 12 acid committee did not consider the proposal of Clotrimazole + lactic acid spray. Hence not recommended for the proposed study. The firm requested to keep their proposal pending as there Medical Director was 13 Dapoxetine HCL + travelling Abroad. Hence the Proposal was Sildenafil Citrate deferred. The firm requested to keep their proposal pending as there Technical Team was 14 Levonorgestrel + travelling Abroad due to preplanned business Ethinylestradiol tour. Hence the Proposal was deferred. Firm present the data of the study. After reviewing the data Committee feel that the firm should conduct well authenticated study with proper geographical distribution of study 15 centers across the country and need to r-FSH generate some more authenticated data as per the approved protocol and submit to the DCG(I) for approval of manufacturing and marketing. 16 Deferred for the next meeting r-FSH 17 Deferred for the next meeting r-HCG 18 Deferred for the next meeting r-FSH 19 Deferred for the next meeting Solifenacin 20 Deferred for the next meeting Fesoterodine 3. RECOMMENDATIONS OF THE (REPRODUCTIVE AND UROLOGY) HELD ON 20.11.2012 The NDAC (Reproductive and Urology) deliberated the proposals on 20.11.2012 and recommended the following:- AGENDA NAME OF DRUG RECOMMENDATIONS NO. The proposed study is for academic purpose. Isosorbide Committee recommended for giving permission 1 Mononitrate to conduct the study. The proposed study is for academic purpose. Misoprostol & 2 Committee recommended for giving permission Mifepristone to conduct the study. The proposed study is for academic purpose. Probiotic Committee recommended for giving permission 3 Supplementation to conduct the study. The proposed study is for academic purpose. Committee recommended for giving permission 4 Probiotic to conduct the study. The firm presented various published reports of clinical trials in support of use of Tadalafil 2.5mg/5mg for the proposed claims. The drug is approved for these conditions in other countries including USA. The committee recommended for giving permission to market tadalafil 2.5mg/5mg tablet for ED and ED with BPH. However for tadalafil for BPH, the committee 5 Tadalafil Tablets recommended that a 3 arm comparative study of Tadalafil 2.5mg vs tadalafil 5mg vs α blocker in statistically significant number of subjects is required to be conducted. Accordingly, protocol etc should be submitted to DCG(I) for his approval. Results of the study should be submitted to the committee for examination. The firm initially applied for Progesterone SR vaginal tablet 200mg/400mg. However during presentation the firm also proposed for 300mg strength. The committee recommended that a 4 arm clinical trial with 200mg vs 300mg vs Progesterone SR 400mg of the formulation vs conventional 6 Vaginal Tablets vaginal tablet should be conducted. Accordingly revised protocol etc. should be submitted to DCG(I) for his approval. The report of the study should be submitted to the committee for examination. The committee opined that the formulation should be termed as lingually disintegrating strips and recommended for giving permission Sildenafil citrate for the proposed bioequivalence study. Based 7 Orally Disintegrating on the result of the BE study, a comparative Strips clinical trial of the proposed formulation vs. conventional tablets is required to be conducted after getting
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