Guidance for Industry
`
`Applications Covered by Section
`505(b)(2)
`
`DRAFT GUIDANCE
`
`This guidance document is being distributed for comment purposes only.
`
`Comments and suggestions regarding this draft document should be submitted within 60 days of
`publication of the Federal Register notice announcing the availability of the draft guidance. Submit
`comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
`Lane, rm. 1061, Rockville, MD 20857. All comments should be identified with the docket number
`listed in the notice of availability that publishes in the Federal Register.
`
`For questions on the content of the draft document contact Virginia Beakes, (301) 594-2041.
`
`U. S. Department of Health and Human Services
`Food and Drug Administration
`Center for Drug Evaluation and Research (CDER)
`October 1999
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`Guidance for Industry
`
`Applications Covered by Section
`505(b)(2)
`
`DRAFT GUIDANCE
`
`For additional copies, contact:
`
`Drug Information Branch
`Division of Communications Management, HFD-210
`Center for Drug Evaluation and Research (CDER)
`5600 Fishers Lane
`Rockville, MD 20857
`(Tel) 301-827-4573
`http://www.fda.gov/cder/guidance/index.htm.
`
`U.S. Department of Health and Human Services
`Food and Drug Administration
`Center for Drug Evaluation and Research (CDER)
`October 1999
`
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`Table of Contents
`
`I.
`
`WHAT IS THE PURPOSE OF THIS GUIDANCE?........................................................................................................... 1
`
`II. WHAT IS A 505(B)(2) APPLICATION? ............................................................................................................................ 2
`
`A. WHAT TYPE OF INFORMATION CAN AN APPLICANT RELY ON?........................................................................................ 2
`B. WHAT KIND OF APPLICATION CAN BE SUBMITTED AS A 505(B)(2) APPLICATION?........................................................3
`
`III. WHAT ARE SOME EXAMPLES OF 505(B)(2) APPLICATIONS? ............................................................................... 4
`
`IV. WHAT CAN'T BE SUBMITTED AS 505(B)(2) APPLICATIONS?................................................................................6
`
`V. WHY DOES IT MATTER IF AN NDA IS A 505(B)(2) APPLICATION?...................................................................... 6
`
`VI.
`
`PATENT AND EXCLUSIVITY PROTECTIONS THAT COULD AFFECT A 505(B)(2) APPLICATION.................7
`
`A. WHAT TYPE OF PATENT AND/OR EXCLUSIVITY PROTECTION IS A 505(B)(2) APPLICATION ELIGIBLE FOR? ................ 7
`B. WHAT COULD DELAY THE APPROVAL OR FILING OF A 505(B)(2) APPLICATION?........................................................... 7
`
`VII.
`
`WHAT SHOULD BE INCLUDED IN 505(B)(2) APPLICATIONS?...........................................................................7
`
`REFERENCES..................................................................................................................................................................................10
`
`GLOSSARY.....................................................................................................................................................................................11
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`GUIDANCE FOR INDUSTRY1
`
`Applications Covered by Section 505(b)(2)
`
`I.
`
`WHAT IS THE PURPOSE OF THIS GUIDANCE?
`
`This guidance identifies the types of applications that are covered by section 505(b)(2) of the Federal
`Food, Drug, and Cosmetic Act (the Act). A 505(b)(2) application is a new drug application (NDA)
`described in section 505(b)(2) of the Act. It is submitted under section 505(b)(1) of the Act and
`approved under section 505(c) of the Act. This guidance also provides further information and
`amplification regarding FDA's regulations at 21 CFR 314.54.
`
`Section 505 of the Act describes three types of new drug applications: (1) an application that contains
`full reports of investigations of safety and effectiveness (section 505(b)(1)); (2) an application that
`contains full reports of investigations of safety and effectiveness but where at least some of the
`information required for approval comes from studies not conducted by or for the applicant and for
`which the applicant has not obtained a right of reference (section 505(b)(2)); and (3) an application that
`contains information to show that the proposed product is identical in active ingredient, dosage form,
`strength, route of administration, labeling, quality, performance characteristics, and intended use, among
`other things, to a previously approved product (section 505(j)). Note that a supplement to an
`application is a new drug application.
`
`Section 505(b)(2) was added to the Act by the Drug Price Competition and Patent Term Restoration
`Act of 1984 (Hatch-Waxman Amendments). This provision expressly permits FDA to rely, for
`approval of an NDA, on data not developed by the applicant. Sections 505(b)(2) and (j) together
`replaced FDA's paper NDA policy, which had permitted an applicant to rely on studies published in the
`scientific literature to demonstrate the safety and effectiveness of duplicates of certain post-1962
`pioneer drug products (see 46 FR 27396, May 19, 1981). Enactment of the generic drug approval
`provision of the Hatch-Waxman Amendments ended the need for approvals of duplicate drugs through
`the paper NDA process by permitting approval under 505(j) of duplicates of approved drugs (listed
`
`
`1This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) at the Food and
`Drug Administration. This guidance document represents the Agency's current thinking on the types of applications
`that may be submitted pursuant to section 505(b)(2) of the Act. It does not create or confer any rights for or on any
`person and does not operate to bind FDA or the public. An alternative approach may be used if such approach
`satisfies the requirements of the applicable statute, regulations, or both.
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`drugs) on the basis of chemistry and bioequivalence data, without the need for evidence from literature
`of effectiveness and safety. Section 505(b)(2) permits approval of applications other than those for
`duplicate products and permits reliance for such approvals on literature or on an Agency finding of
`safety and/or effectiveness for an approved drug product.
`
`Definitions for specific terms used throughout this guidance are given in the Glossary.
`
`II. WHAT IS A 505(B)(2) APPLICATION?
`
`A 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant
`for approval "were not conducted by or for the applicant and for which the applicant has not obtained a
`right of reference or use from the person by or for whom the investigations were conducted" (21 U.S.C.
`355(b)(2)).
`
`A. What type of information can an applicant rely on?
`
`What type of information can an applicant rely on in an application that is based upon studies
`“not conducted by or for the applicant and for which the applicant has not obtained a right of
`reference?”
`
`1.
`
`Published literature
`
`An applicant should submit a 505(b)(2) application if approval of an application will rely
`to any extent on published literature (a literature-based 505(b)(2)). If the applicant
`has not obtained a right of reference to the raw data underlying the published study or
`studies, the application is a 505(b)(2) application; if the applicant obtains a right of
`reference to the raw data, the application may be a full NDA (i.e., one submitted under
`section 505(b)(1)). An NDA will be a 505(b)(2) application if any of the specific
`information necessary for approval is obtained from literature or from another source to
`which the applicant does not have a right of reference, even if the applicant also
`conducted clinical studies to support approval. Note, however, that this does not mean
`any reference to published general information (e.g., about disease etiology, support for
`particular endpoints, methods of analysis) or to general knowledge causes the
`application to be a 505(b)(2) application. Rather, reference should be to specific
`information (clinical trials, animal studies) necessary to the approval of the application.
`
`2.
`
`The Agency’s finding of safety and effectiveness for an approved drug
`
`An applicant should submit a 505(b)(2) application for a change in a drug when
`approval of the application relies on the Agency's previous finding of safety and/or
`effectiveness for a drug. This mechanism, which is embodied in a regulation at 21 CFR
`314.54, essentially makes the Agency's conclusions that would support the approval of
`2
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`a 505(j) application available to an applicant who develops a modification of a drug.
`Section 314.54 permits a 505(b)(2) applicant to rely on the Agency's finding of safety
`and effectiveness for an approved drug to the extent such reliance would be permitted
`under the generic drug approval provisions at section 505(j). This approach is intended
`to encourage innovation in drug development without requiring duplicative studies to
`demonstrate what is already known about a drug while protecting the patent and
`exclusivity rights for the approved drug.
`
`It is possible that an applicant could submit a 505(b)(2) application that relies both on literature
`and upon the Agency’s finding of safety and effectiveness for a previously approved drug
`product (e.g., to support a new claim).
`
`B.
`
`What kind of application can be submitted as a 505(b)(2) application?
`
`1.
`
`New chemical entity (NCE)/new molecular entity (NME)
`
`A 505(b)(2) application may be submitted for an NCE when some part of the data
`necessary for approval is derived from studies not conducted by or for the applicant
`and to which the applicant has not obtained a right of reference. For an NCE, this data
`is likely to be derived from published studies, rather than FDA's previous finding of
`safety and effectiveness of a drug. If the applicant had a right of reference to all of the
`information necessary for approval, even if the applicant had not conducted the studies,
`the application would be a considered a 505(b)(1) application.
`
`2.
`
`Changes to previously approved drugs
`
`For changes to a previously approved drug product, an application may rely on the
`Agency's finding of safety and effectiveness of the previously approved product,
`coupled with the information needed to support the change from the approved product.
` The additional information could be new studies conducted by the applicant or
`published data. This use of section 505(b)(2), described in the regulations at 21 CFR
`314.54, was intended to encourage innovation without creating duplicate work and
`reflects the same principle as the 505(j) application: it is wasteful and unnecessary to
`carry out studies to demonstrate what is already known about a drug. The approach
`was described in a letter to industry dated April 10, 1987, from Dr. Paul D. Parkman,
`then Acting Director of the Center for Drugs and Biologics. This guidance helps to
`clarify and amplify the approaches stated in the April 10, 1987, letter and in the
`regulations.
`
`An applicant should file a 505(b)(2) application if it is seeking approval of a change to
`an approved drug that would not be permitted under section 505(j), because approval
`will require the review of clinical data. However, section 505(b)(2) applications should
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`not be submitted for duplicates of approved products that are eligible for approval
`under 505(j) (see 21 CFR 314.101(d)(9)).
`
`In addition, an applicant may submit a 505(b)(2) application for a change in a drug
`product that is eligible for consideration pursuant to a suitability petition under Section
`505(j)(2)(C) of the Act. In the preamble to the implementing regulations for the Hatch-
`Waxman amendments to the Act, the Agency noted that an application submitted
`pursuant to section 505(b)(2) of the Act is appropriate even when it could also be
`submitted in accordance with a suitability petition as defined at section 505(j)(2)(C) of
`the Act (see 57 FR 17950; April 28, 1992).
`
`III. WHAT ARE SOME EXAMPLES OF 505(B)(2) APPLICATIONS?
`
`Following are examples of changes to approved drugs for which 505(b)(2) applications should be
`submitted. Please note that in particular cases, changes of the type described immediately below may
`not require review of information other than BA or BE studies or data from limited confirmatory testing.2
` In those particular cases, approval of the drug may also be sought in a 505(j) application based on an
`approved suitability petition as described in section 505(j)(2)(C) of the Act. The descriptions below
`address the situation in which the application should be filed as a 505(b)(2) application because
`approval of the application will require review of studies beyond those that can be considered under
`section 505(j). Some or all of the additional information could be provided by literature or reference to
`past FDA findings of safety and effectiveness for approved drugs, or it could be based upon studies
`conducted by or for the applicant or to which it has obtained a right of reference.
`
`• Dosage form. An application for a change of dosage form, such as a change from a solid oral
`dosage form to a transdermal patch, that relies to some extent upon the Agency's finding of
`safety and/or effectiveness for an approved drug.
`
`• Strength. An application for a change to a lower or higher strength.
`
`• Route of administration. An application for a change in the route of administration, such as a
`change from an intravenous to intrathecal route.
`
`• Substitution of an active ingredient in a combination product. An application for a change
`in one of the active ingredients of an approved combination product for another active ingredient
`that has or has not been previously approved.
`
`Following are additional examples of applications that may be accepted pursuant to section 505(b)(2)
`of the Act. Some or all of the additional information could be provided by the literature or reference to
`
`
`2 Limited confirmatory testing is explained in further detail in 54 FR 288872, 28880 (July 10, 1989) and 57 FR 17950,
`17957-58 (April 28, 1992).
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`past FDA findings of safety and effectiveness for approved drugs, or it could be based on studies
`conducted by or for the applicant or to which it has obtained a right of reference.
`
`• Formulation. An application for a proposed drug product that contains a different quality or
`quantity of an excipient(s) than the listed drug where the studies required for approval are
`beyond those considered limited confirmatory studies appropriate to a 505(j) application.
`
`• Dosing regimen. An application for a new dosing regimen, such as a change from twice daily
`to once daily.
`
`• Active ingredient. An application for a change in an active ingredient such as a different salt,
`ester, complex, chelate, clathrate, racemate, or enantiomer of an active ingredient in a listed
`drug containing the same active moiety.
`
`• New molecular entity. In some cases a new molecular entity may have been studied by parties
`other than the applicant and published information may be pertinent to the new application. This
`is particularly likely if the NME is the prodrug of an approved drug or the active metabolite of
`an approved drug. In some cases, data on a drug with similar pharmacologic effects could be
`considered critical to approval.
`
`• Combination product. An application for a new combination product in which the active
`ingredients have been previously approved individually.
`
`•
`
`Indication. An application for a not previously approved indication for a listed drug.
`
`• Rx/OTC switch. An application to change a prescription (Rx) indication to an over-the-counter
`(OTC) indication.
`
`• OTC monograph. An application for a drug product that differs from a product described in
`an OTC monograph (21 CFR 330.11), such as a nonmonograph indication or a new dosage
`form.
`
`• Naturally derived or recombinant active ingredient. An application for a drug product
`containing an active ingredient(s) derived from animal or botanical sources or recombinant
`technology where clinical investigations are necessary to show that the active ingredient is the
`same as an active ingredient in a listed drug.
`
`• Bioinequivalence. Generally, an application for a pharmaceutically equivalent drug product
`must be submitted under section 505(j) of the Act and the proposed product must be shown to
`be bioequivalent to the reference listed drug (21 CFR 314.101(d)(9)). Applications for
`proposed drug products where the rate (21 CFR 314.54(b)(2)) and/or extent (21 CFR
`314.54(b)(1)) of absorption exceed, or are otherwise different from, the 505(j) standards for
`bioequivalence compared to a listed drug may be submitted pursuant to section 505(b)(2) of the
`5
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`Act. Such a proposed product may require additional clinical studies to document safety and
`efficacy at the different rate and extent of delivery. Generally, the differences in rate and extent
`of absorption should be reflected in the labeling of the 505(b)(2) product. The proposed
`product does not need to be shown to be clinically better than the previously approved
`product; however, a 505(b)(2) application should not be used as a route of approval for poorly
`bioavailable generic drug products unable to meet the 505(j) standards for bioequivalence. If
`the proposed product is a duplicate of an already approved product, it should not be submitted
`as a 505(b)(2) application (21 CFR 314.101(d)(9)).
`
`For example, a 505(b)(2) application would be appropriate for a controlled release product
`that is bioinequivalent to a reference listed drug where:
`
`1.
`
`2.
`
`The proposed product is at least as bioavailable as the approved
`pharmaceutically equivalent product (unless it has some other advantage, such
`as smaller peak/trough ratio); or
`
`The pattern of release of the proposed product, although different, is at least as
`favorable as the approved pharmaceutically equivalent product.
`
`IV. WHAT CAN'T BE SUBMITTED AS 505(B)(2) APPLICATIONS?
`
`• An application that is a duplicate of a listed drug and eligible for approval under section 505(j)
`(see 21 CFR 314.101(d)(9)); or,
`
`• An application in which the only difference from the reference listed drug is that the extent to
`which the active ingredient(s) is absorbed or otherwise made available to the site of action is
`less than the listed drug (21 CFR 314.54(b)(1)); or,
`
`• An application in which the only difference from the reference listed drug is that the rate at
`which its active ingredient(s) is absorbed or otherwise made available to the site of action is
`unintentionally less than that of the listed drug (21 CFR 314.54(b)(2)).
`
`V.
`
`WHY DOES IT MATTER IF AN NDA IS A 505(B)(2) APPLICATION?
`
`Unlike a full NDA for which the sponsor has conducted or obtained a right of reference to all the data
`essential to approval, the filing or approval of a 505(b)(2) application may be delayed due to patent or
`exclusivity protections covering an approved product. Section 505(b)(2) applications must include
`patent certifications described at 21 CFR 314.50(i) and must provide notice of certain patent
`certifications to the NDA holder and patent owner under 21 CFR 314.52.
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`VI.
`
`PATENT AND EXCLUSIVITY PROTECTIONS THAT COULD AFFECT A
`505(B)(2) APPLICATION
`
`A.
`
`What type of patent and/or exclusivity protection is a 505(b)(2) application
`eligible for?
`
`A 505(b)(2) application may itself be granted 3 years of Waxman-Hatch exclusivity if one or
`more of the clinical investigations, other than BA/BE studies, was essential to approval of the
`application and was conducted or sponsored by the applicant (21 CFR 314.50(j);
`314.108(b)(4) and (5)). A 505(b)(2) application may also be granted 5 years of exclusivity if it
`is for a new chemical entity (21 CFR 314.50(j); 314.108(b)(2)). A 505(b)(2) application may
`also be eligible for orphan drug exclusivity (21 CFR 314.20-316.36) or pediatric exclusivity
`(section 505A of the Act).
`
`A 505(b)(2) application must contain information on patents claiming the drug or its method of
`use (21 CFR 314.54(a)(1)(v)).
`
`B.
`
`What could delay the approval or filing of a 505(b)(2) application?
`
`Approval or filing of a 505(b)(2) application, like a 505(j) application, may be delayed because
`of patent and exclusivity rights that apply to the listed drug (21 CFR 314.50(i), 314.107, and
`314.108 and section 505A of the Act). This is the case even if the application also includes
`clinical investigations supporting approval of the application.
`
`VII. WHAT SHOULD BE INCLUDED IN 505(B)(2) APPLICATIONS?
`
`The Act (sections 505(b)(1) and (b)(2)) and FDA regulations (21 CFR 314.54) distinguish between
`505(b)(1) and (b)(2) applications. Although the two types of applications must meet the same
`standards for approval (see section 505(b) and (c) of the Act), they differ in source of information to
`support safety and effectiveness, the patent certification requirements, BA/BE evidence, exclusivity bars,
`and processing within the FDA. The requirements for 505(b)(1) and 505(b)(2) applications are
`described at 21 CFR 314.50. Additional requirements for certain 505(b)(2) applications are described
`at 21 CFR 314.54.
`
`A 505(b)(2) application should include the following:
`
`•
`
`•
`
`Identification of those portions of the application that rely on information the applicant does not
`own or to which the applicant does not have a right of reference (for example, for reproductive
`toxicity studies).
`
`If the 505(b)(2) seeks to rely on the Agency's previous finding of safety or efficacy for a listed
`drug or drugs, identification of any and all listed drugs by established name, proprietary name (if
`7
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`any), dosage form, strength, route of administration, name of the listed drug's sponsor, and the
`application number (21 CFR 314.54(a)(1)(iii)). Even if the 505(b)(2) application is based
`solely upon literature and does not rely expressly on an Agency finding of safety and
`effectiveness for a listed drug, the applicant must identify the listed drug(s) on which the studies
`were conducted, if there are any. If the 505(b)(2) application is for an NCE and the 505(b)(2)
`applicant is not relying on literature derived from studies of an approved drug, there may not be
`a listed drug. If there is a listed drug that is the pharmaceutical equivalent to the drug proposed
`in the 505(b)(2) application, that drug should be identified as the listed drug.
`
`Information with respect to any patents that claim the drug or the use of the drug for which
`approval is sought (21 CFR 314.50(h)). This patent information will be published in the Orange
`Book when the application is approved.
`
`Information required under 314.50(j) if the applicant believes it is entitled to marketing
`exclusivity (21 CFR 314.54(a)(1)(vii)).
`
`•
`
`•
`
`• A patent certification or statement as required under section 505(b)(2) of the Act with respect
`to any relevant patents that claim the listed drug and that claim any other drugs on which the
`investigations relied on by the applicant for approval of the application were conducted, or that
`claim a use for the listed or other drug (21 CFR 314.54(a)(1)(vi)).
`
`If there is a listed drug that is the pharmaceutical equivalent of the drug proposed in the
`505(b)(2) application, the 505(b)(2) applicant should provide patent certifications for the
`patents listed for the pharmaceutically equivalent drug. Patent certifications should specify the
`exact patent number(s), and the exact name of the listed drug or other drug even if all relevant
`patents have expired.
`
`•
`
`If an application is for approval of a new indication, and not for the indications approved for the
`listed drug, a certification so stating (21 CFR 314.54(a)(1)(iv).
`
`• A statement as to whether the listed drug(s) identified above have received a period of
`marketing exclusivity (21 CFR 314.108(b)). If a listed drug is protected by exclusivity, filing or
`approval of the 505(b)(2) application may be delayed.
`
`• A Bioavailability/Bioequivalence (BA/BE) study comparing the proposed product to the listed
`drug (if any).
`
`• Studies necessary to support the change or modification from the listed drug or drugs (if any).
`Complete studies of safety and effectiveness may not be necessary if appropriate bridging
`studies are found to provide an adequate basis for reliance upon FDA’s finding of safety and
`effectiveness of the listed drug(s).
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`Before submitting the application, the applicant should submit a plan to the appropriate new
`drug evaluation division identifying the types of bridging studies that should be conducted. The
`applicant should also identify those components of its application for which it expects to rely on
`FDA’s finding of safety and effectiveness of a previously approved drug product. The division
`will critique the plan and provide guidance.
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`REFERENCES
`
`April 10, 1987, letter from then Acting Director of the Center for Drugs and Biologics to all NDA and
`ANDA holders and applicants.
`
`"Abbreviated New Drug Application Regulations; Proposed Rule," Federal Register. Vol. 54, No.
`130, Monday, July 10, 1989, page 28872.
`
`"Abbreviated New Drug Regulations; Final Rule," Federal Register. Vol. 57, No. 82, Tuesday, April
`28, 1992, page 17950.
`
`"Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions; Final Rule,"
`Federal Register. Vol. 59, No. 190, Monday, October 3, 1994, page 50338.
`
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`GLOSSARY
`
`505(b)(2) application: an application submitted under section 505(b)(1) of the Act for a drug for
`which one or more of the investigations relied on by the applicant for approval of the "application were
`not conducted by or for the applicant and for which the applicant has not obtained a right of reference
`or use from the person by or for whom the investigations were conducted" (21 U.S.C. 355(b)(2)).
`
`Active ingredient: "any component that is intended to furnish pharmacological activity or other direct
`effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or
`any function of the body of man or of animals. The term includes those components that may undergo
`chemical change in the manufacture of the drug product and be present in the drug product in a modified
`form intended to furnish the specified activity or effect" (21 CFR 60.3(b)(2)).
`
`Active moiety: "the molecule or ion, excluding those appended portions of the molecule that cause the
`drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent
`derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or
`pharmacological action of the drug substance" (21 CFR 314.108(a)).
`
`Investigations relied on for approval: those without which the application cannot be approved (i.e.,
`animal and human safety tests as well as clinical investigations of effectiveness).
`
`Listed drug: "a new drug product that has an effective approval under section 505(c) of the act for
`safety and effectiveness or under section 505(j) of the act, which has not been withdrawn or suspended
`under section 505(e)(1) through (e)(5) or (j)(5) of the act, and which has not been withdrawn from sale
`for what FDA has determined are reasons of safety or effectiveness. Listed drug status is evidenced by
`the drug product's identification as a drug with an effective approval in the current edition of FDA's
`“Approved Drug Products with Therapeutic Equivalence Evaluations” (the list) or any current
`supplement thereto, as a drug with an effective approval. A drug product is deemed to be a listed drug
`on the date of effective approval of the application or abbreviated application for that drug product" (21
`CFR 314.3(b)).
`
`Literature: published reports of well-controlled studies that support safety or effectiveness; proposed
`and final monographs published in the Federal Register; the data supporting a Federal Register notice
`announcing a product’s safety and/or effectiveness.
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations and any
`current supplement to the publication.
`
`Pharmaceutical equivalent or duplicate: "drug products that contain identical amounts of the
`identical active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety, in identical
`dosage forms, but not necessarily containing the same inactive ingredients, and that meet the identical
`compendial or other applicable standard of identity, strength, quality, and purity, including potency and,
`11
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`Petitioner Torrent Pharmaceuticals Limited - Exhibit 1026 - Page 14
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`

`

`Draft - Not for Implementation
`
`where applicable, content uniformity disintegration times and/or dissolution rates" (21 CFR 320.1(c)).
`Products with different mechanisms of release can be considered to be pharmaceutical equivalents or
`duplicates.
`
`Referenced listed drug: "the listed drug identified by FDA as the drug product upon which an
`applicant relies in seeking approval of its abbreviated application" (21 CFR 314.3(b)).
`
`Right of reference or use: "the authority to rely upon, and otherwise use, an investigation for the
`purpose of obtaining approval of an application, including the ability to make available the underlying
`raw data from the investigation for FDA audit, if necessary" (21 CFR 314.3(b)).
`
`Sponsors have the right of reference to any studies: (1) they conduct, (2) that are conducted for them,
`or (3) for which they formally obtain a documented right of reference.
`
`An applicant is not considered to have a right of reference to published studies, because the applicant
`does not have access to the raw data. However, if the raw data are in the public domain, a right of
`reference is unnecessary.
`
`Suitability petition: A citizen petition submitted to the Agency seeking permission to file an
`abbreviated new drug application for a change from a listed drug in dosage form, strength, route of
`administration, or active ingredient in a combination product. (See section 505(j)(2)(C) of the Act)
`
`\\CDFDA\COMMON\CDERGUID\2853DFT.DOC
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`12
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`Petitioner Torrent Pharmaceuticals Limited - Exhibit 1026 - Page 15
`
`