Esophageal Acid Exposure and Omeprazole Efficacy: A Clinical Study, Study Guides, Projects, Research of Waste Management

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NDA 19-810/S-

Astra Merck Inc.

Attention: Gary P. Horowitz, Ph.D.

725 ChesterbrookBlvd.

Wayne, PA 19087-

Dear Dr. Horowitz:

Please refer to your May 4, 1995 supplementalnew drug application and your resubmission

dated December27, 1995 submitted under section 505(b) of the Federal Food, Drug, and

Cosmetic Act for Prilosec (omeprazole) Delayed-ReleaseCapsules.

We acknowledgereceipt of your amendments dated May 15 and 22, 1995 and April 8 and 10,

August 7, September 20, and October 21, 1996.

The supplementalapplication provides for a new indication: treatment of symptomatic

gastroesophagealreflux disease (GERD).

We have completedthe review of this supplemental application, including the submitteddraft

labeling, and have concluded that adequate information has been presented to demonstratethat

the drug product is safe and effective for use as recommended in the enclosed marked-up draft

labeling. Accordingly, the supplemental application is approved effective on the date of this

letter.

The fnl printed labeling (FPL) must be identical in content to the enclosed marked-up draft_

labeling. In addition, all previous revisions as reflected in the most recently approved

package insert must be included. (^) f

Please submit sixteen copies of the FPL as soon as it is available, in no case more than 30 days

after it is printed. Please individually mount ten of the copies on heavy weight paper or

similar material. For administrative purposes this submission should be designated “FINAL

PRINTED LABELING”for approved supplemental NDA 19-810/S-036. Approval of this

submissionby FDA is not required before the labeling is used.

Should additional information relating to the safety and effectiveness of the drug become

available, revision of that labeling may be required.

In addition, please submit three copies of the titroductory promotional material that you

propose to use for this product. All proposed materials should be submitted in draft or mock-

up form, not final print. Please submit one copy to this Division and two copies of both the

promotional material and the package insefi directly to:

13-

PATENT INFORMATION FOR OMEPRAZOLE

(PRILOSEd) - APPLICATION NUMBER 19810001

Applicant As&aMerck hIC.

Patent No. 4,786, Expiration Date April20,

Type of Patent (^) Drug product and method of use

Name of the Patent Owner (^) AktiebolagetWissle

Representativeauthorized to Astra Merck Inc. receive notice of patent -Cation under waions 505(b)(3) and (j)(2)(B) of the Federal F- DIU~ and cosmetic Act and 21 C.F.R. 5$314.52 and 314.

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The undersigned deolares that Patent No. 4,786,505 covers the formulation, composition and method of use, i.e., Shofi-Term Treatment of Acthe Duodenal Ulcer, &stmesophageaI Reflux Disease (GERD), Severe Erosive Esophagitis, Poorly Responsive Sym@mmticGERD, PathologicalHypmwretory Conditions and Maintenance of Waling of

Erosive Esophagkisi of omeprazole(PRILOSE&). This product is cumntly approved under

Section 505 of the Federal Food, Drugj and Cosmetic Act: ApplicationNo. 19810001.

-H+

~Ott T. Berger, Ph.D. Executive Director, Regulatory Afbirs Astra Merck hC.

13-

The undersigned declares that Patent No. 4,853,230 covers the formulatio~ compoaiti~ and method of use, i.e., Short-Term Treatment of ACtiVC Duodcna! ~ccr,

Gastmsophageal Reflux Disease (GERD), Severe Erosive Esophagitis, Poorly Responsive

Syqtmatic GERD, pathoIo&@ Hyperwmto Conditions and “ d)

Mmtemme of Healing of

ErosiveEsophagitis,of omcpramle (PIULOSE This product is currently approved under

Section505 of the Federal Food, Drug and Cosm&c Act: ApplicationNo. 19810001.

-+ ~Ott T. Bergcr, Ph.D. ExecutiveDirector, Rcgulatoy Afhirs As&aMerck Inc.

13-

PATENT INFORMATION FOR OMEPRAZOLE

~- APPLICATION NUMBER 19$

Appkm AstfaMcrck Inc.

Patent No. 4~5, --- Apxil5, Type of Patent (^) Dq substan~ drug product and method of use

Nam Ofthc patent Owner (^) Astla Aktieboiag . UthollAto Astr8Merckxnc. receivenotice of P8talt artificution under sections 505(b)(3)d (j)(2)(B) of the Falml F@~and CosmeticAct and 21 C.F.R ~~314.52 and 314.

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Approval Date IIIMJ’?L

1. h exclusivity determination will be made for .aI1origi@ ~pplications, but only for certain supplements. Complete Parts II and III of tks EXCIUSXVIVSummary only if you answer “yes” to one or more of the following questions about the submission.

a) Is it an original NDA? YEs

b) Is it an effectiveness supplement?

Es 1~1 NOI /

If yes, what we? (SE1, SE2, etc.) SE

c) Did it require the review of ckitial da% other than to support a safe~ claim or char+ge in labeling related to safety? (If It required review only of bioavadabfii~ or bloequivalence data,answer “no.”)

Y_Es@ NO If your answer is “no” because you believe the study is a bioavailabfli~ study and, therefore, not eligible for exck.sivity, EXPLAIN why it is a bioavailabfii~ study, including your reasons for disagreeing with any arguments made by the applicant that the study was not simply a bioavailabi.li~ study.

If it is a supplement requiring the review of clinical data but it is not an effectiveness supplement, describe the change or claim that is supported by the chical data:

Form OGD-01 1347 Revised8i7195:edited8/ cc:OriginalINDA (^) DivisionFile (^) HFD-85Miq Arm Holovac

d) Did the applicant request exclusivity?

YES I I No/~ If the answer to (d) is “yes,” (^) how many years of exclusiviw did the applicmt request?

m YOU lnim mSWWD “NO” TO u OF THE ABOW QUESTIONS, GO DKIWC~Y TO THE SIGNATUREBLOCKS ON PAGE 8.

2. (^) Has a product with $e same active ingredient(s), dosage foxm, stren=ti, route of administration, and dosug schedule previously been approved by FDA for the same use?

~S/ / NO//I

If yes, NDA #’ (^) Dmg N~e

IF THE ANSWER TO QUESTION 2 IS “M3S, “ GO DDUZCTLYTO TIB3 SIGNAm BLOCKS ON PAGE 8. (^) .-

3. Is this drug product or indication a DESI upgrade?

YES I I NOi L+

IF TID3 ANSWER TO QUESTION3 1S “1%S, “ GO DIRECTLY TO ~ SIGNAm BLOCKS ON PAGE 8 (even if a study was requiredfor the upgrade).

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f

PART III THREE-YEAR l?XCLUSMTl F

OR ND.4’S AND S1TPLEMENTs

To qualify for three years of exclusivity, an application or supplemen; must contain “repom of new clinical investigations (other than bioavailabiliry studies) ess~nual to the approva] of he application and conducted or sponsoredby the applicant. ” This sect~on should be completed only if the answer to PART II, Question1 or 2, was “yes.”

1. Does the^ application contain reports of cIinical^ investigations?^ (The Agency interprets “clinical investigations” to mean investigations conducted on. humans other @ bioavaiIabiliq’ studies.) If the application con@ns clinical mvesciganons ordyby virrue of a right of reference to clinical investigations m another application, answer “yes,” skip to question 3(a). If the answer to 3(a) is “yes” for any investigation referred another application, do not complete remainder of summary for that investigation.

YES /_& NO l_i

~ “NO,” w DIRECTLY TO THE SIGNATUIZE BLOCKS ON PAGE 8.

2. A clinical investigation is “essentizd to the approval” if the Agency could no[ approved the application or supplement wirhout relying on thzu invest$ation. Thus, the investigation is not essential to the approval if 1) no cl,inical investigauon is necessary to support the supplement or applicauon m hght of prewou:ly approved applications (i.e., information otier than clinical trials, such as bioavailabdlty data, would be sufilcient to provide a basis for approval as an AJiDA or 505(b)(2) application because of what is already lmown about a previously approved product), or 2) there are published reports of srudles (other than. those conducted or sponsored by the applicant) or other publicly availabIe data that independently would have been sufficient to. support approvaI of the . application,^ without reference to the clinical^ investigation^ submmed^ in the application.

then to in

have

For the purposes of this section, studies comparing two products with & same ingredlen~(s) me comidered to be bioavailabili~ smdies -

(a) In light of previou.dy approved applications, is a clinical investi$arion (either conducted by the applicant or available from some other source, mchu+ng the published literature) necessary to support approval of the applicanon or supplement? (^) r

YES /_~ NO / I

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If “no, ” state the basis for your conclusion that a clinical trial is not necessa~ for approvaI AND GO DIRECTLY TO SIGNATW BLOCK Oh’PAGE 8:

(b) Did^ the applicant submit a list^ of published^ studies^ relevant to the safe~^ ~d effectiveness of this drug product and a statement that the publicly available data would not independently suppofi approval of the application? . YEs / / No///

(1) (^) If the answer to 2(II) is “yes, ” do YOU ~ersondy know of any reason to disagree with the applicant’s conclusion. If not applicable, answer NO.

YEs/ I No/ /

If yes, explain:

(~) (^) If the answer to 2(%) is ,.’ho, ” are you aware of published studies not conducted or sponsored by the applicant or other publicly availabledata that could independently demommate the safety and effec~ivenessof thisdrug product?

YES l_l h70 f~i

If yes, explain:

(c) (^) If the answers to (b)(l) and (b)(2) were both “no, ” identifj the clinical investigation submitted in the application that are essential to the approval:

Investigation #l, Study # (^) T-16YOIQ

bvestigation #2, Srudy # (^) *

Investigation #3, Study #

c) (^) If theanswersto 3(a) and 3(b) are no, identify each “new” investjgationintie application or supplement that is essential to the approval (i.e., the lnvestigatiom listed in #2(c), less any that are not “new”):

Investigation #’_, Study # T - lMl ICX

Investigation #_, Study #

Investigation #_, Study #

4. (^) To be eiigible for exclusivi~, a new investigation that i! essential-to approval must also have been conducted or :ponsored by the appl~cant. An xnvesdgatxon was “conducted or sponsored by” the apphcant if, before or d:n.ng the conduct of the investigation, 1) the applicant was ye sponso$ of the IND wed m the form WA 1571 fded with the Agency, or 2) the apph~t (or Its predecessor on interest) prowded substantial suppon for the study. Ordmardy, substamudSUpport wdl mean providing 50 percent or more of the cost of the study.

a) (^) For each investigationidentified in response to question 3(c): if the investigation was carried out underan IND, was the applicantidentified on the FDA 1571as the sponsor?

~vestigation #l ~-)6 ~) ~! --”””

IND# (^) YES /_/! NO /<} Explah:

Investigation #~ (^)!

IND#_

Y-Hi / (^)! NO/ (^) / Explain: ~ ! (^) — !

(b) For each !.nvestigation not ctied out under .m ND or for which the appbcmt was not identified ~ the sponsor, dld the apphcarit certify tha~ it or the applicant’s predecessor in interest provided substantial support for the study?

Investigation #1 1- Ibcl A

YES /_/ Explain

Investigation #2 (^)! !

(c)

YES /_/ Explain (^)! No /: (^) / Explain ~

Notsvkhsta.ndingananswerof “yes”\o (a) or (b),-arethere other reasonsto believe that the apphcantshouldnot be credited with hawng “conductedor sponsored”the study?. (Purchasedstudxesmay not be used .asthe b~~ for exclusivity. However, If all rxghts to the drug are purchased (not just studies on the drug), the applicant may be considered to have sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)

YES/ I NO/ Y/

If yes, explain:

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‘-.:OriginaINDA (^) Division File HFD-85 Mary Ann HoIovac

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~’ Page 2 --^ Drug

k

Explain,

Studies in Peoiatric Patients

if none or”tne aDove apply, exp~ain.

as necessary, the foregoing items:

-.

I{hd’?b. Sigfia tire’ of Prep2rer DaLe^.

: Orig MM :D- /Div File NIJA~ion Package ~

‘i

), (^) / ./. / ,. , ,-’ ‘^ .<--

JUN 131995

, MEDICAL OFFICER’S REVIEW

NDA 19-810/S-

PRILOSEC@ Delayed-Release Capsules

Supplemental New Drug Application

for the

Treatment of Symptomatic GERD

(^20) mg once-a-day for

Submitted by Astra

4 to 8 weeks

Merck, PA

Reviewer: Hug’o E. (^) Gallo-Torres, M.D., Ph.D. HFD-