Complete Response Letters
ELC Group: Lutrate®
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, May 29, 2015
Lutrate® Depot (leuprolide acetate for injection), fe 22.5 mg/vial.
CRL_NDA205054_20150529:p1:s141. In the approval of gonadotropin releasing hormone agonists for the palliative treatment of advanced prostate cancer, testosterone levels serve as a surrogate marker of efficacy.
CRL_NDA205054_20150529:p1:s18Provide a batch formula that reflects the proposed composition of the drug product registration batches.
CRL_NDA205054_20150529:p1:s289. As stated in our PreNDA meeting minutes dated October 24, 2012, if you rely for approval on FDA's finding of safety and/or effectiveness for one or more listed drugs, you must establish that such reliance is scientifically appropriate.
CRL_NDA205054_20150529:p1:s4211. Please refer to correspondence dated proprietary name, Lutrate® Depot.
CRL_NDA205054_20150529:p2:s6Pharma manufacturing facility for this application, our ies to the representative of the facility.
CRL_NDA205054_20150529:p2:s16Satisfactory uired before this application may be approved.
CRL_NDA205054_20150529:p2:s17More Complete Response Letters
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