JAN MbTten Jurs Chief Executive Officer Pronova BioPharma Norge AS P.O. Box 420 NO-1327 Lysaker NORWAY. Docket No.

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1 DEPARTMENT OF HEALTH &. HUMAN SERVICES Food and Drug Administration Rockville MD JAN MbTten Jurs Chief Executive Officer Pronova BioPharma Norge AS P.O. Box 420 NO-1327 Lysaker NORWAY Re: Docket No. FDA-2009-P-0398 Dear Mr. Jurs: This letter responds to your citizen petition received on August 4, 2009 (petition). In the Petition, you request that the Food and Drug Administration (FDA or Agency): (1) Refuse to receive or approve any abbreviated new drug application (ANDA) that references Lovaza (omega-3-acid ethyl esters) Capsules as its reference listed drug (RLD) unless the drug product contains the same active ingredient (with the same components, in the same proportions, and from the same sources) as Lovaza (Petition at 1). More specifically, you ask that we refuse to approve an ANDA relying on Lovaza as the RLD unless it satisfies certain omega-3-acid ethyl ester compositional specifications (Petition at 12). (2) Refuse to file or approve any new drug application (NDA) submitted pursuant to section 505(b)(2)\ (a 505(b)(2) NDA) that references Lovaza as a listed drug unless the drug product contains the same active ingredient (with the same components, in the same proportions, and from the same sources) as Lovaza (i.e., satisfying certain omega-3-acid ethyl ester compositional specifications), or the application contains full reports from preclinical and clinical studies conducted by or for the applicant, or for which the applicant has a right of reference, establishing the safety and effectiveness of the subject drug product (Petition at 1). (3) Refuse to receive, file, or approve any ANDA or 505(b)(2) NDA that references Lovaza and relies in part on a demonstration of bioequivalence to Lovaza unless the application contains data that establish bioequivalence to both eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (Petition at I). (4) Refuse to receive, file, or approve any ANDA or 505(b)(2) NDA that references Lovaza and relies in part on a demonstration ofbioequivalence to Lovaza unless the I Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 355(b)(2).

2 test methodology used to establish bioequivalence corrects for baseline concentrations of EP A and DHA present in test subjects (Petition at 1-2). (5) Refuse to receive, fie, or approve any ANDA or 505(b)(2) NDA that references Lovaza unless the amount of cholesterol in the final product is no greater than that in Lovaza (Petition at 2). (6) Refuse to receive, file, or approve any ANDA or 505(b)(2) NDA that references Lovaza in which impurity levels exceed those permitted by the United States Environmental Protection Agencl or those found in Lovaza (Petition at 2). We have carefully considered the Petition. For the reasons stated below, the Petition is denied without comment on whether we wil take the actions that you request. I. BACKGROUND A. Lovaza Lovaza is a combination of ethyl esters of omega-3-fatty acids, principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride levels in patients with severe (2:500 mg/dl) hypertriglyceridemia. FDA approved Lovaza (NDA ) on November 10, Lovaza is available as 1 -gram transparent soft gelatin capsules. B. Section 505( q) of the Act The Petition is subject to section 914 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amended section 505 of the Act (21 U.S.C. 355) by adding new subsection (q). Section 505(q) of the Act applies to certain citizen petitions and petitions for stay of Agency action that request that FDA take any form of action relating to a pending application submitted under section 505(b)(2) or (j) ofthe Act (21 U.S.c. 355(b)(2) or (j) and governs the manner in which these petitions are treated. Among other things, section 505( q)( 1 )(F) of the Act governs the time frame for final Agency action on a petition subject to section 505(q). Under this provision, FDA must take final Agency action on a petition not later than 180 days after the date on which the petition is submitted. The 1 80-day period is not to be extended for any reason. 2 The petition does not actually direct us to specific impurity limits established by the U.S. Environmental Protection Agency pertaining to drug or dietary supplement products containng or derived from fish oil. It does, however, include in its Appendix a guidance published by the U.S. Environmental Protection Agency that provides toxicological summaries and detailed information on risk assessment methods for 25 environmental contaminants and classes of contaminants potentially present in fish, including the contaminants mentioned in the petition, polychlorinated biphenyls (PCBs), dichlorodiphenyltrichloroethane (DDT), and dioxins. 2

3 II. DISCUSSION In the petition, you explain that the active ingredient in Lovaza is a mixture of omega-3-acid ethyl esters. You describe the composition of Lovaza as % w/w EPA ethyl ester and approximately % w/w DHA ethyl ester. Ethyl esters of other omega-3-fatty acids are present at lower amounts in Lovaza, namely docosapentaenoic acid (DP A), stearidonic acid (SDA), heneicosapentaenoic acid (HPA), eicosatetraenoic acid (ETA), and alpha-linolenic acid (ALA). You state in the petition that a proposed United States Pharmacopeia (USP) monograph for omega- 3-acid ethyl esters has been submitted to the USP and that its compositional specifications are consistent with those of the Lovaza NDA (21-654).3 More specifically, the proposed USP monograph would require omega-3-acid ethyl esters to be obtained from the body oil of certain families of fish, with the fish oil undergoing physico-chemical purification processes including urea fractionation followed by molecular distilation. The proposed USP monograph would define omega-3-acid ethyl esters as containing: Petition at 3. (i) 2: 90% EPA, DHA, DP A, SDA, HP A, ETA, and ALA ethyl esters (ii) % EPA and DHA ethyl esters (iii) % EPA ethyl ester (iv) % DHA ethyl ester You state in the petition that the mechanism behind the trglyceride lowering effect of Lovaza is not completely understood, and you argue that it is the unique mixture of major (EPA and DHA) and minor (DPA, SDA, HPA, ETA, and ALA) fish oil-derived omega-3-acid ethyl esters that results in the activity of Lovaza. You request that any applicant seeking approval of an ANDA that references Lovaza be required to be consistent with the omega-3-acid ethyl ester composition specified in the proposed USP monograph and be deri~ed from the same fish oil sources as specified in the proposed USP monograph (Petition at 11-12). You also ask that any applicant seeking approval of a 505(b )(2) NDA that references Lovaza be required either to be consistent with these same compositional characteristics or provide studies establishing the safety and effcacy of the proposed drug product (Petition at 12). You present arguments in the petition that any ANDA or 505(b )(2) NDA relying on Lovaza must include evidence establishing bioequivalence with respect to both EPA and DHA (Petition at 13). You also contend that because both EPA and DHA are present in humans, at levels that vary from one individual to the next, testing to demonstrate bioequiva1ence must correct for baseline concentrations of these substances in test subjects (Petition at 14). 3 The proposed USP monograph, Omega-3 Acid Ethyl Esters, was published in the September-October 2009 edition of Pharmacopeial Forum (Pharmacopeial Forum: Volume No. 35(5) Page 1190). Stearidonic acid (SDA) is referred to as moroctic acid in the proposed USP monograph. 3

4 You state that the fish oil from which Lovaza is manufactured contains saturated fats, cholesterol, arachidonic acid (AA), and environmental marine pollutants such as PCBs, DDT, and dioxins (Petition at 15). You ask that cholesterol and environmental contaminants be appropriately limited in any ANDA or 505(b)(2) products relying on Lovaza (Petition at 2 and 15). With respect to the environmental contaminants, you refer to guidance developed by the U.S. Environmental Protection Agency. For the reasons explained below, we deny your requests without comment on the approvabilty of any ANDA or 505(b )(2) application for omega-3-acid ethyl esters referencing Lovaza because it would be premature and inappropriate to provide such comment at this time. Such an action could, in effect, render a decision on a specific aspect of an ANDA or NDA before the Agency has had an opportnity either to fully consider specific data and information in such an application or to provide the procedural rights that accompany FDA 'actions on applications.4 As noted, you request that we refrain from approving, receiving, or filing any ANDA or 505(b)(2) application for omega-3-acid ethyl esters that references Lovaza unless certain conditions are met or certain data are provided. As described in section I.B of this response, section 505(q)(1)(F) of the Act requires FDA to take final Agency action on the Petition within 180 days of submission. Therefore, we must take action on the Petition at this time. However, FDA has made no final determnation with respect to the data and information necessary to support approval of any ANDAs or 505(b)(2) NDAs for omega-3-acid ethyl esters that reference Lovaza. For complex scientific determinations such as these, our consideration of applications necessarily wil inform our decisions on the nature of the data and information necessar to support an approval, as consideration of the issues raised in a petition may inform the review of applications. In this case, the issues before the Agency involve the compositional characteristics of an active ingredient that is a complex mixture derived from a natural source, the manner in which bioequiva1ence must be demonstrated, and appropriate limits on certain impurities. Given the nature of the scientific issues you raise in the petition, we must consider whether it would be appropriate for us to make a substantive decision at the present time, without the benefit of a complete review in the context of one or more applications and without consideration of established procedural protections for applicants. Were we to grant your requests to impose certain specific requirements on ANDA or 505(b )(2) applicants, we could, in effect, be taking final action on the approvability of specific aspects of an application for an omega-3-acid ethyl ester drug product before we have had an opportnity either to fully review data and information submitted by an applicant or to provide such applicant with appropriate procedural protections. The Act and FDA regulations establish procedural protections for applicants in the context of application review. Section 505 of the Act and FDA's regulations at 21 CFR part 314 describe certain procedures by which the Agency reviews an NDA or ANDA and notifies an applicant if it determnes that an application is approved (21 CFR ) or may not be approved (section 505(c) and 505(j) of the Act, 21 CFR and ), or identifies the deficiencies in the 4 We also note that under applicable statutory and regulatory provisions, we are generally prohibited from disclosing any determinations regarding the fiing or approvability of any particular ANA or NDA before we have reached a final decision on whether to approve or not approve the ANA or NDA. 4

5 application and the steps an applicant may take to respond to the deficiencies (21 CFR ). Tn addition, the statute and regulations describe a specific process through which an applicant whose application the Agency has found does not meet the requirements for approval may challenge the Agency's determnation (section 505(c)(l)(B) and (d) of the Act; 21 CFR ). Under this process, the Agency wil give the applicant notice of an opportnity for a hearing on whether the application is approvab1e, with a specific time frame and process, should the applicant request such a hearing (Id.). These procedures ensure that applicants have an adequate opportnity to challenge a finding by the Agency that a product does not meet the requirements for approval. There is no evidence that in enacting section 505( q) of the Act, Congress intended to short-circuit the application review process or to vitiate an ANDA or NDA applicant's procedural rights by requiring that the Agency make decisions on complex scientific issues specific to pending applications on a piecemeal basis.s We do not interpret section 505(q) to require that the Agency render a final Agency decision within 180 days on specific requirements for approval of any ANDA or NDA for an omega-3-acid ethyl ester drug product when a decision on the approvabi1ity of any such application has not yet been made. We therefore are denying your requests without comment on the requirements for approval of any ANDA or 505(b )(2) NDA that references Lovaza. III. CONCLUSION For the reasons described in this response, the Petition is denied. Sincerely, Janet oodcock, M.D. Director Center for Drug Evaluation and Research 5 In other citizen petition responses, we have responded to certain requests related to general standards for approval (e.g., general bioequivalence criteria for generic drug products or the appropriateness of omitting certain information protected by patent from a proposed drug product's labeling) that may pertain to one or more pending drug applications without commenting on the approvabilty of any particular aspect of a specific pending application. We believe that this approach of describing our general policies or standards for approval of a drug application would not be appropriate in this case because, as stated above, our review of a given ANA or NDA would be expected to inform our decisions regarding the suffciency of the specific data and information needed to demonstrate the sameness of active ingredient or bioequivalence of the complex active ingredient at issue here and to inform our ultimate decisions regarding approvability. We wil continue to evaluate each citizen petition on a case-by-case basis with respect to the appropriateness of responding to the citizen petition's requests vis-a-vis any pending applications. 5

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