Meeting Request Tracking Number: ANDA-219900-PDEV-Meeting-00259762
会议请求追踪编号:ANDA-219900-PDEV-会议-00259762
Pre-ANDA Product Development Meeting
ANDA 申报前产品开发会议
PRELIMINARY RESPONSE
初步回复
Meitheal Pharmaceuticals, Inc.
美泰尔制药有限公司
8700 West Bryn Mawr Avenue, Suite 600S Chicago, IL 60631
伊利诺伊州芝加哥市布林茂尔西路 8700 号 600S 室,邮编 60631
Attention: Roopang Shah
收件人:Roopang Shah
Director, Regulatory Affairs Dear Roopang Shah:
监管事务部主任 尊敬的 Roopang Shah:
This is in reference to your pre-abbreviated new drug application (pre-ANDA) file for leuprolide acetate subcutaneous solution, 14 mg/2.8 mL (1 mg/0.2 mL), referencing Lupron (leuprolide acetate) subcutaneous solution, 14 mg/2.8 mL (1 mg/0.2 mL), approved under new drug application (NDA) 019010, as the reference listed drug (RLD).
本函针对贵方关于醋酸亮丙瑞林皮下注射液(14 mg/2.8 mL,即 1 mg/0.2 mL)的简化新药申请预备案(pre-ANDA),该申请以 NDA 019010 批准的 Lupron(醋酸亮丙瑞林)皮下注射液(14 mg/2.8 mL,即 1 mg/0.2 mL)作为参照列明药品(RLD)。
Reference is also made to your request for a pre-ANDA product development meeting, received on December 27, 2024, and granted on January 7, 2025.
关于贵方于 2024 年 12 月 27 日提交并于 2025 年 1 月 7 日获批的仿制药申请前产品开发会议请求,特此回复。
The Agency’s preliminary responses to your meeting questions are enclosed. The responses provided are based on the information in your submitted meeting package and are subject to revision after comprehensive assessment of your ANDA. We remind you that whether the Office of Generic Drugs (OGD) will receive your ANDA for substantive assessment will be determined during the filing review of your ANDA and that the approvability of your proposed product will be determined during the scientific assessment of your ANDA.
随函附上药监局对贵方会议问题的初步答复。这些答复基于贵方提交的会议资料包所含信息,并将在全面评估贵方仿制药申请(ANDA)后可能进行修订。我们提醒贵方,仿制药办公室(OGD)是否会对贵方 ANDA 进行实质性评估,将在贵方 ANDA 的受理审查阶段确定;而贵方所申报产品的可批准性,将在 ANDA 的科学评估阶段作出判定。
If applicable, provide an electronic version (maximum allowable size is 45 MB) of your updated agenda and any presentation materials (i.e., slides) via the CDER Direct NextGen Collaboration Portal (the portal) (https://edm.fda.gov/) at least 48 hours prior to the scheduled meeting. Do not submit any new data or additional questions not presented in the original meeting package, as this information will not be addressed or discussed at the meeting.
如适用,请至少在预定会议召开前 48 小时,通过 CDER Direct NextGen 协作门户(https://edm.fda.gov/)提交更新后的会议议程电子版(最大允许容量 45MB)及任何演示材料(即幻灯片)。请勿提交原始会议资料包中未包含的新数据或补充问题,因该等信息将不会在会议中予以讨论或处理。
If you have any questions or would like to cancel the meeting, contact Irfan Memon via email at Irfan.Memon@fda.hhs.gov
如有任何疑问或需取消会议,请通过电子邮件联系 Irfan Memon,邮箱地址:Irfan.Memon@fda.hhs.gov.
U.S. Food & Drug Administration Silver Spring, MD 20993 www.fda.gov
美国食品药品监督管理局 马里兰州银泉市 20993 www.fda.gov