72 FR 36 pgs. 8184-8189 - Withdrawal of Approval of 128 Suitability Petitions
Type: NOTICEVolume: 72Number: 36Pages: 8184 - 8189
Docket number: [Docket No. 2004P-0262]
FR document: [FR Doc. E7-3043 Filed 2-22-07; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004P-0262]
Withdrawal of Approval of 128 Suitability Petitions
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 However, these approval decisions are being withdrawn because ANDAs were never submitted and PREA requires that all applications submitted on or after April 1, 1999, for a new active ingredient, new indication,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.
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.
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. | Drug | Petitioner |
|---|---|---|
| 82N-0032/CP6 | Chlorzoxazone 500 milligrams (mg) | Mikart, Inc. |
| 84N-0116/CP1 | Disopyramide Phosphate 200 mg or 300 mg | Biocraft Laboratories, Inc. |
| 84P-0228/CP1 | Acetaminophen 500 mg, Codeine Phosphate 30 mg or 60 mg | McNeil Pharmaceutical |
| 85P-0067/CP1 | Methyltestosterone 25 mg | Star Pharmaceuticals |
| 85P-0074/CP1 | Hydralazine Hydrochloride 25 mg/5 milliliters (mL) | Roxane Laboratories, Inc. |
| 85P-0081/CP1 | Flurazepam Hydrochloride 30 mg/mL | Do. |
| 85P-0084/CP1 | Vincristine Sulfate 2 mg | Bristol Laboratories |
| 85P-0091/CP1 | Flurazepam Hydrochloride 15 mg/5 mL | Roxane Laboratories, Inc. |
| 85P-0095/CP1 | Brompheniramine Maleate 12 mg, Pseudoephedrine Hydrochloride 120 mg | UAD Laboratories, Inc. |
| 85P-0129/CP1 | Propranolol Hydrochloride 160 mg | Verex Laboratories, Inc. |
| 85P-0140/CP1 | Dexbrompheniramine Maleate 6 mg, Pseudoephedrine Hydrochloride 120 mg | Central Pharmaceuticals, Inc. |
| 85P-0140/CP2 | Dexbrompheniramine Maleate 6 mg, Pseudoephedrine Sulfate 120 mg | Do. |
| 85P-0147/CP1 | Ketoconazole 20 mg/mL | Janssen Pharmaceutica |
| 85P-0197/CP1 | Propranolol Hydrochloride 80 mg, 120 mg, 160 mg | Forest Laboratories |
| 85P-0215/CP1 | Disulfiram 500 mg/30 mL | Paddock Laboratories |
| 85P-0238/CP2 | Dexbrompheniramine Maleate 6 mg, Phenylpropanolamine Hydrochloride 75 mg | Bock Pharmacal Co. |
| 85P-0269/CP1 | Codeine Phosphate 10 mg/5 mL, Dexbrompheniramine Maleate 1 mg/5 mL, Phenylpropanolamine Hydrochloride 12.5 mg/5 mL | Do. |
| 85P-0423/CP1 | Benztropine Mesylate 0.5 mg/5 mL | RIM Consulting Corp. |
| 85P-0492/CP1 | Azatadine Maleate 1 mg, Phenylpropanolamine Hydrochloride 75 mg | Smith, Kline French Laboratories |
| 85P-0499/CP1 | Diazepam 2 mg/5 mL | Carolina Medical Products Co. |
| 85P-0510/CP1 | Spironolactone 25 mg/5 mL | Do. |
| 85P-0515/CP1 | Lorazepam 0.5 mg, 1 mg, or 2 mg | Wyeth Laboratories, Inc. |
| 85P-0516/CP1 | Oxazepam 15 mg or 30 mg | Do. |
| 85P-0543/CP1 | Acetaminophen 300 mg, Codeine Phosphate 30 mg | Softan, Inc. |
| 85P-0543/CP2 | Acetaminophen 500 mg, Codeine Phosphate 7.5 or 15 mg | Do. |
| 85P-0543/CP3 | Acetaminophen 500 mg, Oxycodone Hydrochloride 5 mg | Do. |
| 85P-0563/CP1 | Ibuprofen 300, 400, or 600 mg | Do. |
| 85P-0581/CP1 | Acetaminophen 500 mg, Propoxyphene Hydrochloride 32 mg | Do. |
| 86P-0045/CP1 | Propranolol Hydrochloride 10, 20, 40, 60, 80, 90 mg | Nutripharm, Inc. |
| 86P-0055/CP1 | Spironolactone 25 mg/5 mL | Carolina Medical Products Co. |
| 86P-0123/CP1 | Cholestyramine 4 grams (g) | Parke-Davis, Division of Warner-Lambert Co. |
| 86P-0200/CP1 | Acetaminophen 650 mg, Codeine Phosphate 15 mg | Mikart, Inc. |
| 86P-0242/CP1 | Floxuridine 500 mg/5 mL | Quad Pharmaceuticals, Inc. |
| 86P-0292/CP1 | Lorazepam 1 mg/5 mL | Roxane Laboratories, Inc. |
| 86P-0359/CP1 | Aspirin 356.4 mg, Caffeine 30 mg, Dihydrocodeine Bitartrate 16 mg | Central Pharmaceuticals, Inc. |
| 86P-0361/CP1 | Acetaminophen 325 mg, Aspirin 325 mg, Codeine Phosphate 30 mg | Bock Pharmacal Co. |
| 86P-0427/CP1 | Hydrochlorothiazide 50 mg, Triamterene 75 mg | Par Pharmaceutical, Inc. |
| 86P-0474/CP1 | Cholestyramine 500 mg | Bristol-Myers Squibb |
| 87P-0004/CP1 | Fluocinonide 0.05% | Richard Hamer Assoc. |
| 87P-0037/CP1 | Lorazepam 0.5 mg, 1 mg, 2 mg | Applied Laboratories, Inc. |
| 87P-0101/CP1 | Verapamil Hydrochloride 40 mg/5 mL or 80 mg/5 mL | MY-K Laboratories, Inc. |
| 87P-0233/CP1 | Verapamil Hydrochloride 120 mg or 240 mg | Searle Research Development |
| 87P-0242/CP1 | Ibuprofen 800 mg | Sidmak Laboratories, Inc. |
| 87P-0265/CP1 | Dexbrompheniramine Maleate 6 mg, Phenypropanolamine Hydrochloride 75 mg | Bock Pharmacal Co. (King Spalding) |
| 87P-0268/CP1 | Loperamide Hydrochloride 2 mg | Kross, Inc. |
| 87P-0301/CP1 | Cholestyramine Resin 4 g | Ciba-Geigy Corp. |
| 87P-0314/CP1 | Clemastine Fumarate 1.34 mg, Pseudoephedrine Hydrochloride 120 mg | Sandoz Consumer Healthcare Group |
| 87P-0323/CP1 | Acetaminophen 160 mg/5 mL, Codeine Phosphate 6 mg/5 mL | Kleinfeld, Kaplan Becker |
| 87P-0335/CP1 | Triamterene 50 mg, Hydrochlorothiazide 25 mg | Par Pharmaceutical, Inc. |
| 87P-0340/CP1 | Nifedipine 10 mg or 20 mg | Do. |
| 87P-0367/CP1 | Phenytoin Sodium 100 mg, 250 mg/vial | Lyphomed, Inc. |
| 87P-0399/CP1 | Propranolol Hydrochloride 40 mg or 80 mg/5 mL, Hydrochlorothiazide 25 mg/5 mL | Burditt, Bowles, Radzius Rudberry |
| 88P-0011/CP1 | Cyclophosphamide 20 mg/mL, 500 mL pharmacy bulk pack (PBP) | Baxter Healthcare Corp. |
| 88P-0036/CP1 | Chlorhexidine Gluconate 0.5% | Arent, Fox, Kinter, Plotkin Kahn |
| 88P-0061/CP1 | Homatropine Methylbromide 1.5 mg, Hydrocodone Bitartrate 5 mg | Kleinfeld, Kaplan Becker |
| 88P-0149/CP1 | Leucovorin Calcium 1 mg/mL | Roxane Laboratories, Inc. |
| 88P-0277/CP1 | Quinidine Sulfate 300 mg | A. H. Robins |
| 88P-0350/CP1 | Clemastine Fumarate 1.34 mg, Phenylpropanolamine Hydrochloride 75 mg | Scientific Consulting of VA, Inc. |
| 88P-0379/CP1 | Cyclophosphamide 20 mg/mL, 250 mL PBP | Baxter Healthcare Corp. |
| 88P-0391/CP1 | Prednisone 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 25 mg, or 50 mg | B.F. Ascher Co., Inc. |
| 89P-0028/CP1 | Hydrocortisone Valerate 0.2% | McKenna, Conner Cuneo |
| 89P-0029/CP1 | Hydrocortisone Valerate 0.2% | Do. |
| 89P-0071/CP1 | Morphine Sulfate 30 mg | Ethypharm/Oxford Research Intl. Corp. |
| 89P-0399/CP1 | Carbamazepine 200 mg/5 mL | Guidelines, Inc. |
| 89P-0435/CP1 | Pentamidine Isethionate 100 mg/mL | Astra Pharmaceutical Products, Inc. |
| 90P-0049/CP1 | Hydrocortisone Acetate 2.5% or 1% | Ferndale Laboratories, Inc. |
| 90P-0084/CP1 | Chlorzoxazone 250 mg | Mikart, Inc. |
| 90P-0154/CP1 | Hydrocortisone Acetate 1% | Ferndale Laboratories, Inc. |
| 90P-0198/CP1 | Clobetasol Propionate 0.05%, RLD = Temovate | Kross, Inc. |
| 90P-0436/CP1 | Nifedipine 30 mg, 60 mg, 90 mg | KV Pharmaceutical Co. |
| 91P-0348/CP1 | Albuterol Sulfate 4 mg | Richard Hamer Associates, Inc. |
| 92P-0048/CP2 | Triazolam 0.125 mg/5 mL | Roxane Laboratories, Inc. |
| 92P-0101/CP1 | Hydrocortisone Acetate 2.5% | Hogan Hartson |
| 92P-0282/CP1 | Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 5 mg | Mikart, Inc. |
| 92P-0282/CP2 | Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 7.5 mg | Do. |
| 92P-0282/CP3 | Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 2.5 mg | Do. |
| 92P-0282/CP4 | Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 10 mg | Do. |
| 92P-0332/CP1 | Propranolol Hydrochloride 40 mg | Flemington Pharmaceutical Corp. |
| 92P-0335/CP1 | Albuterol Sulfate 2 mg, 4 mg | WE Pharmaceuticals, Inc. |
| 92P-0336/CP1 | Prednisone 5 mg or 10 mg | Do. |
| 92P-0381/CP1 | Cytarabine 20 mg/mL, 12.5 mL | Bristol-Myers Squibb Co. |
| 92P-0500/CP1 | Timethoprim 25 mg/5 mL | Ascent Pharmaceuticals, Inc. |
| 93P-0048/CP1 | Cimetidine 200, 300, 400 or 800 mg | Flemington Pharmaceuticals Corp. |
| 93P-0049/CP1 | Propranolol Hydrochloride 10, 20, 60, 80, 90 mg | Do. |
| 93P-0314/CP1 | Acetaminophen 500 mg, Codeine Phosphate 45 mg | Mikart, Inc. |
| 93P-0332/CP1 | Loperamide Hydrochloride 1 mg | Asta Medica GmbH |
| 93P-0333/CP1 | Prednisone 1, 2.5, 20, 50 mg | Dura Pharmaceuticals |
| 93P-0346/CP1 | Acetaminophen 325 mg, Butalbital 50 mg, Caffeine 40 mg, Hydrocodone Bitartrate 5 mg | Mikart, Inc. |
| 93P-0367/CP1 | Terfenadine 60 mg, Pseudoephedrine 120 mg | Eurand America |
| 93P-0446/CP1 | Morphine Sulfate 15 mg, 60 mg, 90 mg, 100 mg | Ethypharm |
| 93P-0459/CP1 | Methyltestosterone 25 mg | ICN Pharmaceuticals, Inc. |
| 94P-0182/CP1 | Acetaminophen 120 mg, Codeine Phosphate 12 mg | WE Pharmaceuticals, Inc. |
| 94P-0186/CP1 | Sulfamethoxazole 200 mg, Trimethoprim 40 mg | Dura Pharmaceuticals |
| 94P-0199/CP1 | Lorazepam 1 mg/10 mL | Roxane Laboratories, Inc. |
| 94P-0210/CP1 | Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 60 mg | Mikart, Inc. |
| 94P-0211/CP1 | Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 30 mg | Do. |
| 94P-0212/CP1 | Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 15 mg | Do. |
| 94P-0263/CP1 | Fluorouracil 5% | Bradley Pharmaceuticals, Inc. |
| 94P-0432/CP1 | Methylprednisolone 16 mg, 24 mg, 32 mg | Dura Pharmaceuticals |
| 94P-0433/CP1 | Leucovorin Calcium 10 mg/mL 350 mg vial | Lederle Laboratories |
| 94P-0433/CP2 | Leucovorin Calcium 10 mg/mL 5 mL vial | Do. |
| 95P-0008/CP1 | Captopril 25 mg/mL | Roxane Laboratories, Inc. |
| 95P-0100/CP1 | Carbidopa/Levodopa 25/100 mg, 25/250 mg | Athena Neurosciences, Inc. |
| 95P-0223/CP1 | Hydrocortisone Butyrate 0.1% | McKenna Cuneo, L.L.P. |
| 95P-0268/CP1 | Acyclovir Sodium 5 mg/mL | Wilmer, Cutler, Pickering |
| 95P-0277/CP1 | Cholestyramine 2 g | Mayrand Pharmaceuticals, Inc. |
| 95P-0279/CP1 | Butalbital 50 mg, Acetaminophen 325 mg, Caffeine 40 mg, Hydrocodone Bitartrate 10 mg | Mikart, Inc. |
| 95P-0279/CP2 | Butalbital 50 mg, Acetaminophen 325 mg, Caffeine 40 mg, Hydrocodone Bitartrate 7.5 mg | Do. |
| 95P-0279/CP3 | Butalbital 50 mg, Acetaminophen 500 mg, Caffeine 40 mg, Hydrocodone Bitartrate 10 mg | Do. |
| 95P-0279/CP4 | Butalbital 50 mg, Acetaminophen 500 mg, Caffeine 40 mg, Hydrocodone Bitartrate 7.5 mg | Do. |
| 95P-0326/CP1 | Nifedipine 30 mg, 60 mg, 90 mg | KV Pharmaceutical Co. |
| 95P-0328/CP1 | Metronidazole 0.75% | RNB Pharmaceutical Co. |
| 96P-0018/CP1 | Potassium Chloride 20 milliequivalents (meq) | KV Pharmaceutical Co. |
| 96P-0021/CP1 | Aspirin 650 mg Butalbital 50 mg | Savage Laboratories, Division of Altana, Inc. |
| 96P-0054/CP1 | Potassium Chloride 10 meq | KV Pharmaceutical Co. |
| 96P-0079/CP1 | Pentoxyfylline 400 mg | Do. |
| 96P-0307/CP1 | Acyclovir 5% | Pitney, Hardin, Kipp Szuch |
| 96P-0376/CP1 | Hydrocortisone Acetate 90 mg | Do. |
| 96P-0510/CP1 | Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Cardiazem CD | Labopharm, Inc. |
| 97P-0155/CP1 | Mefenamic Acid 250 mg | Pitney, Hardin, Kipp Szuch |
| 97P-0192/CP1 | Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Dilacor XR | Labopharm, Inc. |
| 97P-0195/CP1 | Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Tiazac | Do. |
| 97P-0387/CP1 | Albuterol Sulfate 2 mg and 4 mg | Richard Hamer Assoc., Inc. |
| 97P-0404/CP1 | Famotidine 10 mg | Thomas Blake, R.Ph. |
| 98P-0068/CP1 | Clobetasol Propionate 0.05%, RLD = Temovate E | Richard Hamer Associates, Inc. |
| 98P-0146/CP1 | Ifosfamide 50 mg/mL, 20 mL, and 60 mL | Mitchall G. Clark |
| 98P-0199/CP1 | Captopril 25 mg/5 mL | Miran Consulting, Inc. |
| 98P-0745/CP1 | Econazole 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.
Dated: February 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3043 Filed 2-22-07; 8:45 am]
BILLING CODE 4160-01-S