Complete Response Letters
Actavis LLC, an indirect, wholly-owned subsidiary of Teva Pharmaceuticals U.S.A. Inc.: Pemetrexed
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jun 26, 2018
Actavis LLC, an indirect, wholly-owned subsidiary of Teva Pharmaceuticals U.S.A. Inc.
CRL_NDA208419_20180626:p1:s7Cosmetic Act for Pemetrexed Injection © 95 mg/mL.
CRL_NDA208419_20180626:p1:s15Provide updated drug product release and stability specifications for all three presentations of Pemetrexed Injection, to reflect the change of © in the formulation and the addition of a new presentation.
CRL_NDA208419_20180626:p1:s22We recommend that you add an assay test for the |" in the drug product specifications.
CRL_NDA208419_20180626:p1:s23Also indicate the dilution of the drug product that is proposed for routine bacterial endotoxins testing at the S.C.
CRL_NDA208419_20180626:p1:s39S.C. Sindan-Pharma S.R.L. facilities for the new drug product formulation proposed in the unsolicited amendment dated October 4, 2017, has not been provided.
CRL_NDA208419_20180626:p1:s42Provide English translations of current approved foreign labeling not previously submitted.
CRL_NDA208419_20180626:p2:s31We have the following comments/recommendations that are not approvability issues; however, we recommend the following be implemented prior to approval of this NDA:
CRL_NDA208419_20180626:p3:s6More Complete Response Letters
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