10 th SEC- (Reproductive & Urology)meetingheld on at CDSCO (HQ), FDA Bhawan, Kotla road, New Delhi PROGRAMME SCHEDULE

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1 10 th SEC- (Reproductive & Urology)meetingheld on at CDSCO (HQ), FDA Bhawan, Kotla road, New Delhi PROGRAMME SCHEDULE Recommendation:- The 10 th SEC (Reproductive and Urology) meeting deliberated the proposals on and recommended the following:- 1 Fesoterodine Fumarate /09-DC (Pt-A) 2 Tamoxifene citrate 12-62/14-DC New Drugs Division proposals M/s Intas withdrawn Dr.Gadipudi Avanthi The proposal is an Academic Study. After detailed deliberation the Committee recommended to conduct the Clinical trial entitled Tamoxifen for Ovulation Induction in Infertile Women with Polycystic Ovarian Syndrome who did not conceive with three cycles of Clomiphene citrate - A prospective clinical study. 3 Pentosan Polysulfate Sodium 100 mg Capsule 12-01/12DC(Pt.9 -WestCoast/ Pentosan) /10- DC(Pt-D) Ulipristal Acetate Tablets 5mg M/s WestCoast M/s. Cipla Pvt. Ltd. Mumbai. The drug was referred by the Parliamentary Standing Committee for expert opinion on continued marketing of the drug in the country. The firm has presented the published literatures and the details of the PSUR submitted by the company. The committee deliberated the data in detailed and recommended as under: The firm should submit:- 1. India Specific safety data vis-à-vis Global Data. 2. Detail PSUR with line listing. 3. The follow up data of the patients on the drug. 4. BE study report on the drug. After detailed deliberation of the clinical trial protocol entitled A randomized, open label, Parallelgroup, active-comparator controlled, multi-centre study to evaluate the efficacy and safety of Ulipristal acetate (5mg tablets), as compared with Leuprolide acetate (3.75 mg intramuscular injection) for 12 weeks, in the prospective treatment of moderate to severe symptomatic uterine fibroids, presented by the firm, the Committee recommended that the firm should submit revised protocol as discussed during the presentation with the inclusion of the following: 1. The age group as years female instead of years. Page 1 of 6

2 2. Iron supplementation. 3. Endometrial evaluation. The sites to be included should be geographically distributed in the country with 50 percent Govt. Medical College / Institutions. Bioequivalence protocol presented by the firm was approved by the Committee. The firm is required to present the BE study report to the Committee along with revised clinical trial protocol /10- DC(Pt-E) Ulipristal Acetate Tablets 5mg M/s Intas Pharmaceutical pvt. Ltd, Gujrat. The firm did not come for presentation /08- DC(Pt-A) Imidafenacin orally disintegrating (OD) Tablets 7 Imidafenacin orally disintegrating (OD) Tablets /08-DC (Pt-B) 8 Triptorelin pamoate PR M/s. Eisai Pharmaceuticals India Pvt. Ltd., Mumbai. M/s. MSN Laboratories Pvt. Ltd., Hyderabad. The firm requested for Local clinical trial waiver based on Phase I, Phase II, Phase III and Phase IV published data. After the deliberation the Committee recommended that the firm should conduct local clinical trial and submit protocol etc. in line with the similar permission granted earlier for the same product to other firm. The firm presented the protocol entitled Double blind, Randomized, Multicentric, Parallel group, Comparative Phase III study to evaluate the Efficacy and Safety of Imidafenacin versus Solifenacin Succinate in patients with symptoms associated with overactive bladder before the Committee whereas the firm submitted the protocol entitled Double blind, Randomized, Multicentric, Parallel group, Comparative Phase III study to evaluate the Efficacy and Safety of Imidafenacin versus Placebo in patients with symptoms associated with overactive bladder. Therefore the Committee recommended the firm to submit the protocol presented to the DCG (I) office for further deliberation before the Committee. The firm also presented the BE protocol and the Committee recommended the BE study and asked the BE report before the Committee along with revised clinical trial protocol. Subsequent New Drug Divisionproposals M/s Menarini Firm withdrawn the proposal Page 2 of 6

3 Tablet 11.25mg 12-55/2013- DC(PT-a- Menarini) 9 Metformin SR Tablet 500/1000mg 12-17/09- DC(Pt- Abbott) 10 Sildenafil Citrate orally disintegrating srtrips 25mg/50mg (waiver phase IV) /2010- dc(pt-a-nut) 11 Progesterone 400 mg Sustained Release tablet F /2015-DC (Pt-Sun-CT) SND M/S Abbott Laboratories M/s NU Therapeutic M/s Sun pharmaceuticals Ltd The committee opined that firm shall conduct Phase III clinical trial and accordingly protocol shall be placed before the committee. Firm presented the proposal before the committee. The committee opined that Phase IV trial waiver cannot be considered. The committee recommended for the proposed BE & CT trial study with a following conditions subject shall be included in the proposed BE study. 2. Firm shall include GOVT Research institute from rth region also. The report of the study shall be placed before the committee. 12 r-hu-hcg 4-285/Intas/ 14 BD 13 r-h-fsh 4-273/cadila healthcare/14 BD 14 Minitouch Device (An Endiometrial Ablation Device) M/s Intas Biopharmaceuti cal Ltd., M/s. Cadila Healthcare Ltd M/s. Regulatory Solutions India Biologicals Proposals After detail deliberation, the committee approved the study protocol to carry out phase III trial of r-hu-hcg, if the product is bio-similar to reference drug (Ovitrelle- Merck). After detail deliberation, The committee approved the study protocol to carry out phase III trial of r-h-fsh, if the product is bio-similar to reference drug. The committee has also recommended to include the two more Government hospitals i.e. PGI- Chandigarh and AIIMS- New Delhi. Medicals devicesproposals The firm has applied for import of the Minitouch Device endometrial ablation device manufactured by M/s. MicroCube LLC, Warm Springs Blvd, Fremont CA 94539, USA. The case was referred to DGHS seeking for clarification whether can be Page 3 of 6

4 29/Misc/3/201 4-DC (47) regulated as Medical device. The DGHS has recommended to take the opinion of Gynecologist experts. The Minitouch system is designed for treating heavy menstrual bleeding (HMB) in women in an outpatient setting. Since medications are ineffective for most women, currently HMB is treated by Hysterectomy (permanent removal of the uterus via surgery), an expensive and invasive procedure. It comprises a disposable, single use device that is connected to a counter-top size generator. The device does not deliver any pharmaceutical or chemical agents to the uterus. The device is inserted transcervically into the uterine cavity. The Minitouch device delivers microwave energy to the uterine endometrium for about seconds. The dielectric heat raises the temperature to over 50 C and creates thermal necrosis of the endometrium. The necrosed tissue is no longer able to bleed. The said device is composed of Gold coatewdnitinol ; Polyolefin; PEBAX (PolyetherBlockAmide); PEEK (Polyetheretherketone); Clear Silicon Rubber; Hysol M-31CL; Black ink. All material of construction are known and tested biocompatible materials that are routinely used in medical devices and come in contact with the human tissue for no more than 5 minutes. The proposed device has received a CE mark in Europe and is freely sold in Europe Union. After detailed deliberation, the committee opined that the said device does not fall in any of the notified category of the medical device. Therefore the committee opined that the suggestion from DCGI be sought in this regard. The committee opined that the firm is required to submit safety and efficacy data (both Indian and Global) in support of the said device. Page 4 of 6

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