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Notice

Withdrawal of Approval of 128 Suitability Petitions

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 128 suitability petitions. This action is being taken in accordance with the Pediatric Research Equity Act of 2003 (PREA). Prior to PREA's enactment, FDA had approved these suitability petitions to permit abbreviated new drug applications (ANDAs) to be submitted for drugs that had a different active ingredient, dosage form, or route of administration than their reference listed drugs (RLDs). However, these approval decisions are being withdrawn because ANDAs were never submitted and PREA requires that all applications submitted on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. This action is being taken without prejudice. Any of the suitability petitions may be resubmitted for action by the agency in accordance with current law.

DATES:

This notice is effective March 26, 2007.

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FOR FURTHER INFORMATION CONTACT:

Cecelia M. Parise, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5845.

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SUPPLEMENTARY INFORMATION:

PREA (Public Law 108-155) was enacted on December 3, 2003. Among other things, section 2 of PREA requires that all drug applications submitted on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. As a result, FDA is withdrawing its approval for 128 suitability petitions for which ANDAS were never submitted. The approval decisions, made prior to the enactment of PREA, would have permitted ANDAs to be submitted for certain drugs that have a different active ingredient, dosage form, or route of administration than their RLDs. No ANDAs were submitted for these drugs pursuant to these suitability petitions prior to April 1, 1999, and any such application submitted on or after April 1, 1999, would be required to contain the safety and effectiveness assessments required by PREA, unless waived or deferred. According to § 314.93(e)(1)(i) (21 CFR 314.93(e)(1)(i)), a suitability petition may not be approved if investigations must be conducted to show the safety and effectiveness of the drug product. In addition, according to § 314.93(f), FDA may withdraw approval of a suitability petition if it receives information demonstrating that the petition no longer satisfies the conditions of § 314.93(e). Under PREA, safety and effectiveness investigations in pediatric subpopulations would be required for the drug products proposed by these suitability petitions, unless the requirement is waived or deferred. Therefore, these suitability petitions no longer satisfy the regulatory requirements for approval. Pursuant to § 314.93(f), FDA is withdrawing approval of the 128 suitability petitions listed in the following table:

Petition No.DrugPetitioner
82N-0032/CP6Chlorzoxazone 500 milligrams (mg)Mikart, Inc.
84N-0116/CP1Disopyramide Phosphate 200 mg or 300 mgBiocraft Laboratories, Inc.
84P-0228/CP1Acetaminophen 500 mg, Codeine Phosphate 30 mg or 60 mgMcNeil Pharmaceutical
85P-0067/CP1Methyltestosterone 25 mgStar Pharmaceuticals
85P-0074/CP1Hydralazine Hydrochloride 25 mg/5 milliliters (mL)Roxane Laboratories, Inc.
85P-0081/CP1Flurazepam Hydrochloride 30 mg/mLDo.
85P-0084/CP1Vincristine Sulfate 2 mgBristol Laboratories
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85P-0091/CP1Flurazepam Hydrochloride 15 mg/5 mLRoxane Laboratories, Inc.
85P-0095/CP1Brompheniramine Maleate 12 mg, Pseudoephedrine Hydrochloride 120 mgUAD Laboratories, Inc.
85P-0129/CP1Propranolol Hydrochloride 160 mgVerex Laboratories, Inc.
85P-0140/CP1Dexbrompheniramine Maleate 6 mg, Pseudoephedrine Hydrochloride 120 mgCentral Pharmaceuticals, Inc.
85P-0140/CP2Dexbrompheniramine Maleate 6 mg, Pseudoephedrine Sulfate 120 mgDo.
85P-0147/CP1Ketoconazole 20 mg/mLJanssen Pharmaceutica
85P-0197/CP1Propranolol Hydrochloride 80 mg, 120 mg, 160 mgForest Laboratories
85P-0215/CP1Disulfiram 500 mg/30 mLPaddock Laboratories
85P-0238/CP2Dexbrompheniramine Maleate 6 mg, Phenylpropanolamine Hydrochloride 75 mgBock Pharmacal Co.
85P-0269/CP1Codeine Phosphate 10 mg/5 mL, Dexbrompheniramine Maleate 1 mg/5 mL, Phenylpropanolamine Hydrochloride 12.5 mg/5 mLDo.
85P-0423/CP1Benztropine Mesylate 0.5 mg/5 mLRIM Consulting Corp.
85P-0492/CP1Azatadine Maleate 1 mg, Phenylpropanolamine Hydrochloride 75 mgSmith, Kline & French Laboratories
85P-0499/CP1Diazepam 2 mg/5 mLCarolina Medical Products Co.
85P-0510/CP1Spironolactone 25 mg/5 mLDo.
85P-0515/CP1Lorazepam 0.5 mg, 1 mg, or 2 mgWyeth Laboratories, Inc.
85P-0516/CP1Oxazepam 15 mg or 30 mgDo.
85P-0543/CP1Acetaminophen 300 mg, Codeine Phosphate 30 mgSoftan, Inc.
85P-0543/CP2Acetaminophen 500 mg, Codeine Phosphate 7.5 or 15 mgDo.
85P-0543/CP3Acetaminophen 500 mg, Oxycodone Hydrochloride 5 mgDo.
85P-0563/CP1Ibuprofen 300, 400, or 600 mgDo.
85P-0581/CP1Acetaminophen 500 mg, Propoxyphene Hydrochloride 32 mgDo.
86P-0045/CP1Propranolol Hydrochloride 10, 20, 40, 60, 80, 90 mgNutripharm, Inc.
86P-0055/CP1Spironolactone 25 mg/5 mLCarolina Medical Products Co.
86P-0123/CP1Cholestyramine 4 grams (g)Parke-Davis, Division of Warner-Lambert Co.
86P-0200/CP1Acetaminophen 650 mg, Codeine Phosphate 15 mgMikart, Inc.
86P-0242/CP1Floxuridine 500 mg/5 mLQuad Pharmaceuticals, Inc.
86P-0292/CP1Lorazepam 1 mg/5 mLRoxane Laboratories, Inc.
86P-0359/CP1Aspirin 356.4 mg, Caffeine 30 mg, Dihydrocodeine Bitartrate 16 mgCentral Pharmaceuticals, Inc.
86P-0361/CP1Acetaminophen 325 mg, Aspirin 325 mg, Codeine Phosphate 30 mgBock Pharmacal Co.
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86P-0427/CP1Hydrochlorothiazide 50 mg, Triamterene 75 mgPar Pharmaceutical, Inc.
86P-0474/CP1Cholestyramine 500 mgBristol-Myers Squibb
87P-0004/CP1Fluocinonide 0.05%Richard Hamer Assoc.
87P-0037/CP1Lorazepam 0.5 mg, 1 mg, 2 mgApplied Laboratories, Inc.
87P-0101/CP1Verapamil Hydrochloride 40 mg/5 mL or 80 mg/5 mLMY-K Laboratories, Inc.
87P-0233/CP1Verapamil Hydrochloride 120 mg or 240 mgSearle Research & Development
87P-0242/CP1Ibuprofen 800 mgSidmak Laboratories, Inc.
87P-0265/CP1Dexbrompheniramine Maleate 6 mg, Phenypropanolamine Hydrochloride 75 mgBock Pharmacal Co. (King & Spalding)
87P-0268/CP1Loperamide Hydrochloride 2 mgKross, Inc.
87P-0301/CP1Cholestyramine Resin 4 gCiba-Geigy Corp.
87P-0314/CP1Clemastine Fumarate 1.34 mg, Pseudoephedrine Hydrochloride 120 mgSandoz Consumer Healthcare Group
87P-0323/CP1Acetaminophen 160 mg/5 mL, Codeine Phosphate 6 mg/5 mLKleinfeld, Kaplan & Becker
87P-0335/CP1Triamterene 50 mg, Hydrochlorothiazide 25 mgPar Pharmaceutical, Inc.
87P-0340/CP1Nifedipine 10 mg or 20 mgDo.
87P-0367/CP1Phenytoin Sodium 100 mg, 250 mg/vialLyphomed, Inc.
87P-0399/CP1Propranolol Hydrochloride 40 mg or 80 mg/5 mL, Hydrochlorothiazide 25 mg/5 mLBurditt, Bowles, Radzius & Rudberry
88P-0011/CP1Cyclophosphamide 20 mg/mL, 500 mL pharmacy bulk pack (PBP)Baxter Healthcare Corp.
88P-0036/CP1Chlorhexidine Gluconate 0.5%Arent, Fox, Kinter, Plotkin & Kahn
88P-0061/CP1Homatropine Methylbromide 1.5 mg, Hydrocodone Bitartrate 5 mgKleinfeld, Kaplan & Becker
88P-0149/CP1Leucovorin Calcium 1 mg/mLRoxane Laboratories, Inc.
88P-0277/CP1Quinidine Sulfate 300 mgA. H. Robins
88P-0350/CP1Clemastine Fumarate 1.34 mg, Phenylpropanolamine Hydrochloride 75 mgScientific Consulting of VA, Inc.
88P-0379/CP1Cyclophosphamide 20 mg/mL, 250 mL PBPBaxter Healthcare Corp.
88P-0391/CP1Prednisone 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 25 mg, or 50 mgB.F. Ascher & Co., Inc.
89P-0028/CP1Hydrocortisone Valerate 0.2%McKenna, Conner & Cuneo
89P-0029/CP1Hydrocortisone Valerate 0.2%Do.
89P-0071/CP1Morphine Sulfate 30 mgEthypharm/Oxford Research Intl. Corp.
89P-0399/CP1Carbamazepine 200 mg/5 mLGuidelines, Inc.
89P-0435/CP1Pentamidine Isethionate 100 mg/mLAstra Pharmaceutical Products, Inc.
90P-0049/CP1Hydrocortisone Acetate 2.5% or 1%Ferndale Laboratories, Inc.
90P-0084/CP1Chlorzoxazone 250 mgMikart, Inc.
90P-0154/CP1Hydrocortisone Acetate 1%Ferndale Laboratories, Inc.
90P-0198/CP1Clobetasol Propionate 0.05%, RLD = TemovateKross, Inc.
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90P-0436/CP1Nifedipine 30 mg, 60 mg, 90 mgKV Pharmaceutical Co.
91P-0348/CP1Albuterol Sulfate 4 mgRichard Hamer Associates, Inc.
92P-0048/CP2Triazolam 0.125 mg/5 mLRoxane Laboratories, Inc.
92P-0101/CP1Hydrocortisone Acetate 2.5%Hogan & Hartson
92P-0282/CP1Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 5 mgMikart, Inc.
92P-0282/CP2Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 7.5 mgDo.
92P-0282/CP3Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 2.5 mgDo.
92P-0282/CP4Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 10 mgDo.
92P-0332/CP1Propranolol Hydrochloride 40 mgFlemington Pharmaceutical Corp.
92P-0335/CP1Albuterol Sulfate 2 mg, 4 mgWE Pharmaceuticals, Inc.
92P-0336/CP1Prednisone 5 mg or 10 mgDo.
92P-0381/CP1Cytarabine 20 mg/mL, 12.5 mLBristol-Myers Squibb Co.
92P-0500/CP1Timethoprim 25 mg/5 mLAscent Pharmaceuticals, Inc.
93P-0048/CP1Cimetidine 200, 300, 400 or 800 mgFlemington Pharmaceuticals Corp.
93P-0049/CP1Propranolol Hydrochloride 10, 20, 60, 80, 90 mgDo.
93P-0314/CP1Acetaminophen 500 mg, Codeine Phosphate 45 mgMikart, Inc.
93P-0332/CP1Loperamide Hydrochloride 1 mgAsta Medica GmbH
93P-0333/CP1Prednisone 1, 2.5, 20, 50 mgDura Pharmaceuticals
93P-0346/CP1Acetaminophen 325 mg, Butalbital 50 mg, Caffeine 40 mg, Hydrocodone Bitartrate 5 mgMikart, Inc.
93P-0367/CP1Terfenadine 60 mg, Pseudoephedrine 120 mgEurand America
93P-0446/CP1Morphine Sulfate 15 mg, 60 mg, 90 mg, 100 mgEthypharm
93P-0459/CP1Methyltestosterone 25 mgICN Pharmaceuticals, Inc.
94P-0182/CP1Acetaminophen 120 mg, Codeine Phosphate 12 mgWE Pharmaceuticals, Inc.
94P-0186/CP1Sulfamethoxazole 200 mg, Trimethoprim 40 mgDura Pharmaceuticals
94P-0199/CP1Lorazepam 1 mg/10 mLRoxane Laboratories, Inc.
94P-0210/CP1Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 60 mgMikart, Inc.
94P-0211/CP1Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 30 mgDo.
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94P-0212/CP1Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 15 mgDo.
94P-0263/CP1Fluorouracil 5%Bradley Pharmaceuticals, Inc.
94P-0432/CP1Methylprednisolone 16 mg, 24 mg, 32 mgDura Pharmaceuticals
94P-0433/CP1Leucovorin Calcium 10 mg/mL 350 mg vialLederle Laboratories
94P-0433/CP2Leucovorin Calcium 10 mg/mL 5 mL vialDo.
95P-0008/CP1Captopril 25 mg/mLRoxane Laboratories, Inc.
95P-0100/CP1Carbidopa/Levodopa 25/100 mg, 25/250 mgAthena Neurosciences, Inc.
95P-0223/CP1Hydrocortisone Butyrate 0.1%McKenna & Cuneo, L.L.P.
95P-0268/CP1Acyclovir Sodium 5 mg/mLWilmer, Cutler, Pickering
95P-0277/CP1Cholestyramine 2 gMayrand Pharmaceuticals, Inc.
95P-0279/CP1Butalbital 50 mg, Acetaminophen 325 mg, Caffeine 40 mg, Hydrocodone Bitartrate 10 mgMikart, Inc.
95P-0279/CP2Butalbital 50 mg, Acetaminophen 325 mg, Caffeine 40 mg, Hydrocodone Bitartrate 7.5 mgDo.
95P-0279/CP3Butalbital 50 mg, Acetaminophen 500 mg, Caffeine 40 mg, Hydrocodone Bitartrate 10 mgDo.
95P-0279/CP4Butalbital 50 mg, Acetaminophen 500 mg, Caffeine 40 mg, Hydrocodone Bitartrate 7.5 mgDo.
95P-0326/CP1Nifedipine 30 mg, 60 mg, 90 mgKV Pharmaceutical Co.
95P-0328/CP1Metronidazole 0.75%RNB Pharmaceutical Co.
96P-0018/CP1Potassium Chloride 20 milliequivalents (meq)KV Pharmaceutical Co.
96P-0021/CP1Aspirin 650 mg Butalbital 50 mgSavage Laboratories, Division of Altana, Inc.
96P-0054/CP1Potassium Chloride 10 meqKV Pharmaceutical Co.
96P-0079/CP1Pentoxyfylline 400 mgDo.
96P-0307/CP1Acyclovir 5%Pitney, Hardin, Kipp & Szuch
96P-0376/CP1Hydrocortisone Acetate 90 mgDo.
96P-0510/CP1Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Cardiazem CDLabopharm, Inc.
97P-0155/CP1Mefenamic Acid 250 mgPitney, Hardin, Kipp & Szuch
97P-0192/CP1Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Dilacor XRLabopharm, Inc.
97P-0195/CP1Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = TiazacDo.
97P-0387/CP1Albuterol Sulfate 2 mg and 4 mgRichard Hamer Assoc., Inc.
97P-0404/CP1Famotidine 10 mgThomas Blake, R.Ph.
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98P-0068/CP1Clobetasol Propionate 0.05%, RLD = Temovate ERichard Hamer Associates, Inc.
98P-0146/CP1Ifosfamide 50 mg/mL, 20 mL, and 60 mLMitchall G. Clark
98P-0199/CP1Captopril 25 mg/5 mLMiran Consulting, Inc.
98P-0745/CP1Econazole Nitrate 1%Do.

This action is being taken without prejudice. Any of these petitions may be resubmitted for action by the agency in accordance with current law.

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Dated: February 13, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E7-3043 Filed 2-22-07; 8:45 am]

BILLING CODE 4160-01-S