CENTER FOR DRUG EVALUATION AND RESEARCH
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`APPROVAL PACKAGE FOR:
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`APPLICATION NUMBER
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`21-572
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`Correspondence
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`DEPARTMENT OF HEALTH 8. HUMAN SERVICES
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`Public Health Service
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`MAH _ 5 2003
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`Food and Drug Administration
`Rockville MD 20%7
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`Counsel to Cubist Pharmaceuticals. Inc.
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`/1
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`RE: Cubist Pharmaceuticals. lnc.,'Small Business “’a‘tver Request ——‘
`Drug Application 21-572 for Cidecin (daptomycin for injection)
`
`'for New
`
`Dear Mr. . "‘
`
`This responds to your December 18, 2002, and December 3], 2002, letters on behalf of Cubist
`Pharmaceuticals, Inc. (Cubist) requesting a waiver of the human drug application fee for new
`drug application (NDA) 21—572 for Cidecin (daptomycin for injection) under the small
`business waiver provision of section 736(d)(l)(D)' of the Federal Food, Drug, and Cosmetic
`Act (the Act) (Waiver Request — For the reasons described below, the Food and
`Drug Administration (FDA) grants the request from Cubist Pharmaceuticals, Inc. (Cubist) for a
`small business waiver of the application fee for an NDA for Cidecin.
`
`According to your waiver request, Cubist is a small business with fewer than 500 employees
`including employees. of your affiliates. You also note that NDA 21-572 for Cidecin is the first
`human drug application submitted to FDA by Cubist for review.
`
`Under the ACI, a waiver of the application fee shall be granted to a small business for the first
`human drug application that a small business or its affiliate2 submits to the FDA for review. The
`small business waiver provision entitles a qualified small business to a waiver when the business
`meets the following criteria: (I) the business must employ fewer than 500 persons, including
`employees of-its affiliates, and (2) the marketing application must be the first human drug
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`application, Within the meaning of the Act, that a company or its affiliate submits to FDA.
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`FDA‘s decision to grant-Cubist’s request for a small business waiver for the NDA for Cidecrn is
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`based on the following findings. First, the Small Business Administration (SBA) determined and
`stated in its letter dated January 15. 2003. that Cubist has fewer than 500 employees including its
`affiliates:
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`' 2| U.S.C. 379hthI)(D).
`7 'The term 'afliliate‘ means a business entity that has a relationship with a second bminess entity if, directly or
`indirectly — (A) one business entity controls, or bu the power to control, the other business entity; or (B) a third
`pany controls, or has the power to control. both of the business entities" (21 U.S.C. 3793(9)).
`“W._ “v
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`Cubist Pharmaceuticals. lnc.
`Waiver Request t _.
`Page 2
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`C&T Acquisition Corporation; Terragen Discovery. Inc; Cubist Pharmaceuticals
`Canada, lne.; and Cubist Pharmaceuticals UK, Ltd.
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`Second. according to FDA records. the marketing application for Cidecin. NDA 21—572. is the
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`first human drug application, within the meaning of the Act. to be subrrtitted to FDA by Cubist or
`any of its affiliates. Consequently. your request for a small business waiver of the application
`fee for NDA 21-572 Cidecin is granted, provided that FDA receives the marketing application
`for Cidecin no later than January 15. 2004. 1 year after the effective date of the size
`determination made by SBA.
`‘
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`If FDA refuses to file the application or Cubist withdraws the application before it is filed by
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`FDA, 3 reevaluation of the waiver may be required should the company resubmit its marketing
`application. If this situation occurs, Cubist should contact this office approximately 90 days
`before it expects to resubmit its marketing application to determine whether it continues to
`
`qualify for a waiver.
`
`We have notified the FDA Office of Financial Management (OFM) of this waiver decision and
`have asked them to waive the application fee for NDA 21-572. FDA records show that Cubist’s
`NDA 21 572 was submitted on December 20, 2002, and FDA was notified of the $533,400
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`payment for the application on December 23. 2002. Cubist should receive a refund of $533,400.
`If Cubist does not receive this refund within 30 days of the date of this letter, please contact
`Donna Simms, OFM, at 301—827-5042.
`
`FDA plans to disclose to the public information about its actions granting or denying waivers
`and reductions. This disclosure will be consistent with the laws and regulations governing the
`disclosure of confidential commercial or financial information.
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`If any billing questions arise concerning the marketing application or if you have any questions
`about this small business waiver, please contact Beverly Friedman, Michael Jones, or 'I'awni
`Scbwemer at 301-594-2041.
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`Sineerel y.
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`IS/
`Zane A. Axelrad
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`/
`
`Associate Director for Policy
`Center for Drug Evaluation and Research _
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`."
`
`l
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`

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`Cubist Phannacculicals. lnc.
`Waiver Roqucst #
`Page 3
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`BCC:
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`HFD-S M. Jones
`HFD~5
`B. Friedman ‘
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`HFD—S
`HFD-S
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`Chronological File
`Cubist Pharmaceuticals. Inc. waiver file
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`HFM-l 10 C. Vincent/R. Eastep
`HFA~103 S. Farrah (RECORD ON PAYMENT AND ARREARS LIST)
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`HFA~120 D. Simms - (REFUND PENDING)
`HF-‘ZO
`F. Claunls
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`Drafted: B. Friedman 1/28/03
`Edited: O.Pritzlaff2/l9/03
`Reviewed: J. Axelrad 2/26/03
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`Rcviscd punctuation; B. Fricdman 2/27/03,
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`Reviewed and signed: .l. Axelrad
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`February 27. 2003
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`\\CD5029\PDUFA\\VAIYEPAPENDTNG\Cubist\0231014 2 .doc
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`RedéétEd-_ji_?—_
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`page? of trade
`sécfét and/0r -
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`'confidential
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`commerCial. -
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`hinfOrmation'
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`3‘
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`1
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`5: 6: DEPARTMENTOFHEALTH&HUMANSERVICES
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`Public Health Service
`
`Food and Dmg Administration
`Rockville. MD 20857
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`NDA 21-572
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`Cubist Pharmaceuticals, Inc.
`'Attention: David H. Schubert
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`Vice President, Regulatory Affairs and Quality
`65 Hayden Avenue
`Lexington, MA 02421
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`‘
`
`Dear Mr. Schubert:
`
`Please refer to your December 20, 2002 new drug application (NDA) submitted under section
`505(b) ofthe Federal Food, Drug, and Cosmetic Act for Cidecin® (daptomycin for injection)
`Intravenous Injection.
`
`On June 16, 2003, we received your June 16, 2003 major amendment to this application. The
`receipt date is within 3 months of the user fee goal date. Therefore, we are extending the goal
`date by three months to provide time for a full review of the submission. The extended user fee
`goal date is September 20, 2003.
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`If you have any questions, call LTJ G Raquel Peat, Regulatory Health Project Manager, at (301)
`827-2125.
`
`Sincerely,
`
`{See apfigéd electronic signaturepage}
`
`Janice Soreth, MD.
`Director
`
`Division of Anti-Infective Drug Products
`Office of Drug Evaluation IV
`Center for Drug Evaluation and Research
`
`fl
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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.
`
`Janice Soreth
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`6/18/03 02:24:46 PM
`
`

`

`
`
` 6 DEPARTMENTorHEALTH3.- HUMANSERVICES PublicHealthSW09
`
`Food and Drug Administration
`Rockville. MD 20857
`
`NDA 21-572
`
`Cubist Pharmaceuticals, Inc.
`Attention: David H. Schubert
`
`Vice President, Regulatory Affairs and Quality
`65 Hayden Avenue
`Lexington, MA 02421
`
`Dear Mr. Schubert:
`
`We have received your new drug application (NDA) submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act for the following:
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`Name of Drug Product: Cidecin® (daptomycin for injection) Intravenous Injection
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`Review Priority Classification: Priority (P)
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`Date of Application: December 19, 2002
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`Date of Receipt: December 20, 2002
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`Our Reference Number: NDA 21-572
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`Unless we notify you within 60 days ofthe receipt date that the application is not sufficiently
`complete to permit a substantive review, we will file the application on February 18, 2003 in
`accordance with 2] CFR 314.101(a). Ifwe file the application, the user fee goal date will be
`June 20, 2003.
`
`Under 21 CFR 314.]02(c), you may request an informal conference with this Division (to be
`held approximately 90 days from the above receipt date) for a brief report on the status of the
`review but not on the ultimate approvability of the application. Alternatively, you may choose to
`receive a report by telephone.
`
`Please cite the NDA number listed above at the top of the first page of any communications
`concerning this application. Address all communications concerning this NDA as follows:
`
`.... ~. _,
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`

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`NDA 21-572
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`Page 2
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`US. Postal Service:
`
`Center for Drug Evaluation and Research
`Division of Anti-lnfective Drug Product
`Attention: Division Document Room, HFD-SZO
`5600 Fishers Lane
`
`Rockville, Maryland 20857
`
`Courier/Overnight Mail:
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division ofAnti-Infective Drug Products, BED-520
`Attention: Document Room
`
`9201 Corporate Boulevard
`Rockville, Maryland 20850
`
`If you have any questions, call LTJG Raquel Peat, Regulatory Project Manager, at (30]) 827-
`2125.
`
`Sincerely, \
`{Sec appendficlmnic signaturepage}
`
`Frances EeSane
`Chief, Project Management Staff
`Division of Anti-Infective Drug Products
`Office of Drug Evaluation IV
`Center for Drug Evaluation and Research
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
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`..__..-____.._____..-_-——
`
`Beth Duvall—Miller
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`2/19/03 11:15:11 AM
`BDM acting for FVL
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`. ~__-
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