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`RESEARCH
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`APPLICATION NUMBER:
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`209472Orig1s000
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`CLINICAL PHARMACOLOGY AND
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`BIOPHARMACEUTICS REVIEW(S)
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`Clinical Pharmacology Review Memo
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`NDA: 209472 (SDN 30)
`Submission Date: 8/9/2019
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`Drug Name: Pemfexy (Pemetrexed Injection)
`Dosage Form: 500 mg/20 mL (25 mg/mL)
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`Applicant: Eagle Pharmaceuticals, Inc. (Eagle)
`Submission Type: NDA Amendment – Request for Final Approval
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`NDA 209472 for Pemfexy (Pemetrexed Injection), 500 mg/20 mL (25 mg/mL), was originally
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`submitted on 12/30/2016 (SDN 1) for the treatment of patients with locally advanced or
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`metastatic non-squamous non-small cell lung cancer and mesothelioma in combination with
`cisplatin. Pemfexy is a ready-to-dilute liquid intravenous formulation which was developed to
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`eliminate the reconstitution step of the Reference Listed Drug (RLD) ALIMTA.
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` Pemfexy is expected to have
`the same efficacy and safety profile as for the RLD approved product.
`In accordance with the Agency’s Tentative Approval Letter dated 10/26/2017, Eagle
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`submitted an amendment request for final approval of their NDA six months prior to the date
`that this NDA is eligible for final approval. The purpose of this amendment is to provide the
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`legal/regulatory basis for the final approval request, to update the container and carton labeling
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`revised in accordance with the Agency’s recommendations dated 12/21/2017 and to update the
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`prescribing information in accordance with the currently approved prescribing information for
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`ALIMTA.
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`There is no new clinical pharmacology information submitted in this NDA amendment. The
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`updated revised labeling is acceptable from the clinical pharmacology perspective.
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`Action:
`No action is indicated.
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`Reference ID: 4500051
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`1
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`(b) (4)
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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
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`SAFAA BURNS
`10/01/2019 04:35:21 PM
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`JEANNE FOURIE ZIRKELBACH
`10/02/2019 02:39:59 PM
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`Reference ID: 4500051
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`Clinical Pharmacology Review
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`NDA: 209472 (SDN 1)
`Submission Date: 12/30/2016
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`Drug Name: Pemetrexed Injection
`Dosage Form: 25 mg/mL aqueous solution in single-dose vials
`Applicant: Eagle Pharmaceuticals, Inc. (Eagle)
`Submission Type: Original NDA – 505(b)(2)
`Pemetrexed Injection, 25 mg/mL, is a ready-to dilute (RTD) new formulation being submitted in
`accordance with Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act wherein the
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`pharmacology and safety of this new formulation is based on the established efficacy and safety
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`attributes of the Reference Listed Drug (RLD), ALIMTA (pemetrexed for injection) for
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`Intravenous Use (Eli Lilly’s NDA 21462, approval date: 2/4/2004). ALIMTA is being marketed
`as a sterile single-use vial containing 100 mg or 500 mg of pemetrexed disodium, which upon
`reconstitution with 0.9% Sodium Chloride Injection contains 25 mg/mL pemetrexed.
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`NDA 209472 does not contain any clinical or clinical pharmacology studies as the Applicant
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`requests a waiver of the requirement to submit evidence of the in vivo bioavailability (BA) or
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`bioequivalence (BE) of Pemetrexed Injection, 25 mg/mL, to ALIMTA.
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`Pemetrexed Injection, 25 mg/mL is intended for the same indications and contains the same
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`active moiety (pemetrexed) as the Reference Listed Drug (RLD) ALIMTA.
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` As both products are aqueous solutions, safety,
`efficacy and PK profiles are anticipated to be comparable between Pemetrexed Injection, 25
`mg/mL and ALIMTA.
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`Action:
`No action is indicated.
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`Reference ID: 4078860
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`1
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`(b) (4)
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`SAFAA BURNS
`04/03/2017
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`JEANNE FOURIE ZIRKELBACH
`04/06/2017
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`Reference ID: 4078860
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