[Federal Register Volume 72, Number 36 (Friday, February 23, 2007)]
[Notices]
[Pages 8184-8189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3043]


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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.

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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approval decisions are being withdrawn because ANDAs were never 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 
Sec.  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 
Sec.  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 Sec.  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 Sec.  314.93(f), FDA is withdrawing approval of 
the 128 suitability petitions listed in the following table:

------------------------------------------------------------------------
  Petition
    No.                      Drug                       Petitioner
------------------------------------------------------------------------
82N-0032/    Chlorzoxazone 500 milligrams (mg)    Mikart, Inc.
 CP6
------------------------------------------------------------------------
84N-0116/    Disopyramide Phosphate 200 mg or     Biocraft Laboratories,
 CP1          300 mg                               Inc.
------------------------------------------------------------------------
84P-0228/    Acetaminophen 500 mg,                McNeil Pharmaceutical
 CP1         Codeine Phosphate 30 mg or 60 mg
------------------------------------------------------------------------
85P-0067/    Methyltestosterone 25 mg             Star Pharmaceuticals
 CP1
------------------------------------------------------------------------
85P-0074/    Hydralazine Hydrochloride 25 mg/5    Roxane Laboratories,
 CP1          milliliters (mL)                     Inc.
------------------------------------------------------------------------
85P-0081/    Flurazepam Hydrochloride 30 mg/mL    Do.
 CP1
------------------------------------------------------------------------
85P-0084/    Vincristine Sulfate 2 mg             Bristol Laboratories
 CP1
------------------------------------------------------------------------

[[Page 8185]]

 
85P-0091/    Flurazepam Hydrochloride 15 mg/5 mL  Roxane Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
85P-0095/    Brompheniramine Maleate 12 mg,       UAD Laboratories, Inc.
 CP1         Pseudoephedrine Hydrochloride 120
              mg
------------------------------------------------------------------------
85P-0129/    Propranolol Hydrochloride 160 mg     Verex Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
85P-0140/    Dexbrompheniramine Maleate 6 mg,     Central
 CP1         Pseudoephedrine Hydrochloride 120     Pharmaceuticals, Inc.
              mg
------------------------------------------------------------------------
85P-0140/    Dexbrompheniramine Maleate 6 mg,     Do.
 CP2         Pseudoephedrine Sulfate 120 mg
------------------------------------------------------------------------
85P-0147/    Ketoconazole 20 mg/mL                Janssen Pharmaceutica
 CP1
------------------------------------------------------------------------
85P-0197/    Propranolol Hydrochloride 80 mg,     Forest Laboratories
 CP1          120 mg, 160 mg
------------------------------------------------------------------------
85P-0215/    Disulfiram 500 mg/30 mL              Paddock Laboratories
 CP1
------------------------------------------------------------------------
85P-0238/    Dexbrompheniramine Maleate 6 mg,     Bock Pharmacal Co.
 CP2         Phenylpropanolamine Hydrochloride
              75 mg
------------------------------------------------------------------------
85P-0269/    Codeine Phosphate 10 mg/5 mL,        Do.
 CP1         Dexbrompheniramine Maleate 1 mg/5
              mL,
             Phenylpropanolamine Hydrochloride
              12.5 mg/5 mL
------------------------------------------------------------------------
85P-0423/    Benztropine Mesylate 0.5 mg/5 mL     RIM Consulting Corp.
 CP1
------------------------------------------------------------------------
85P-0492/    Azatadine Maleate 1 mg,              Smith, Kline & French
 CP1         Phenylpropanolamine Hydrochloride     Laboratories
              75 mg
------------------------------------------------------------------------
85P-0499/    Diazepam 2 mg/5 mL                   Carolina Medical
 CP1                                               Products Co.
------------------------------------------------------------------------
85P-0510/    Spironolactone 25 mg/5 mL            Do.
 CP1
------------------------------------------------------------------------
85P-0515/    Lorazepam 0.5 mg, 1 mg, or 2 mg      Wyeth Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
85P-0516/    Oxazepam 15 mg or 30 mg              Do.
 CP1
------------------------------------------------------------------------
85P-0543/    Acetaminophen 300 mg,                Softan, Inc.
 CP1         Codeine Phosphate 30 mg
------------------------------------------------------------------------
85P-0543/    Acetaminophen 500 mg,                Do.
 CP2         Codeine Phosphate 7.5 or 15 mg
------------------------------------------------------------------------
85P-0543/    Acetaminophen 500 mg,                Do.
 CP3         Oxycodone Hydrochloride 5 mg
------------------------------------------------------------------------
85P-0563/    Ibuprofen 300, 400, or 600 mg        Do.
 CP1
------------------------------------------------------------------------
85P-0581/    Acetaminophen 500 mg,                Do.
 CP1         Propoxyphene Hydrochloride 32 mg
------------------------------------------------------------------------
86P-0045/    Propranolol Hydrochloride 10, 20,    Nutripharm, Inc.
 CP1          40, 60, 80, 90 mg
------------------------------------------------------------------------
86P-0055/    Spironolactone 25 mg/5 mL            Carolina Medical
 CP1                                               Products Co.
------------------------------------------------------------------------
86P-0123/    Cholestyramine 4 grams (g)           Parke-Davis, Division
 CP1                                               of Warner-Lambert Co.
------------------------------------------------------------------------
86P-0200/    Acetaminophen 650 mg,                Mikart, Inc.
 CP1         Codeine Phosphate 15 mg
------------------------------------------------------------------------
86P-0242/    Floxuridine 500 mg/5 mL              Quad Pharmaceuticals,
 CP1                                               Inc.
------------------------------------------------------------------------
86P-0292/    Lorazepam 1 mg/5 mL                  Roxane Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
86P-0359/    Aspirin 356.4 mg,                    Central
 CP1         Caffeine 30 mg,                       Pharmaceuticals, Inc.
             Dihydrocodeine Bitartrate 16 mg
------------------------------------------------------------------------
86P-0361/    Acetaminophen 325 mg,                Bock Pharmacal Co.
 CP1         Aspirin 325 mg,
             Codeine Phosphate 30 mg
------------------------------------------------------------------------

[[Page 8186]]

 
86P-0427/    Hydrochlorothiazide 50 mg,           Par Pharmaceutical,
 CP1         Triamterene 75 mg                     Inc.
------------------------------------------------------------------------
86P-0474/    Cholestyramine 500 mg                Bristol-Myers Squibb
 CP1
------------------------------------------------------------------------
87P-0004/    Fluocinonide 0.05%                   Richard Hamer Assoc.
 CP1
------------------------------------------------------------------------
87P-0037/    Lorazepam 0.5 mg, 1 mg, 2 mg         Applied Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
87P-0101/    Verapamil Hydrochloride 40 mg/5 mL   MY-K Laboratories,
 CP1          or 80 mg/5 mL                        Inc.
------------------------------------------------------------------------
87P-0233/    Verapamil Hydrochloride 120 mg or    Searle Research &
 CP1          240 mg                               Development
------------------------------------------------------------------------
87P-0242/    Ibuprofen 800 mg                     Sidmak Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
87P-0265/    Dexbrompheniramine Maleate 6 mg,     Bock Pharmacal Co.
 CP1         Phenypropanolamine Hydrochloride 75   (King & Spalding)
              mg
------------------------------------------------------------------------
87P-0268/    Loperamide Hydrochloride 2 mg        Kross, Inc.
 CP1
------------------------------------------------------------------------
87P-0301/    Cholestyramine Resin 4 g             Ciba-Geigy Corp.
 CP1
------------------------------------------------------------------------
87P-0314/    Clemastine Fumarate 1.34 mg,         Sandoz Consumer
 CP1         Pseudoephedrine Hydrochloride 120     Healthcare Group
              mg
------------------------------------------------------------------------
87P-0323/    Acetaminophen 160 mg/5 mL,           Kleinfeld, Kaplan &
 CP1         Codeine Phosphate 6 mg/5 mL           Becker
------------------------------------------------------------------------
87P-0335/    Triamterene 50 mg,                   Par Pharmaceutical,
 CP1         Hydrochlorothiazide 25 mg             Inc.
------------------------------------------------------------------------
87P-0340/    Nifedipine 10 mg or 20 mg            Do.
 CP1
------------------------------------------------------------------------
87P-0367/    Phenytoin Sodium 100 mg, 250 mg/     Lyphomed, Inc.
 CP1          vial
------------------------------------------------------------------------
87P-0399/    Propranolol Hydrochloride 40 mg or   Burditt, Bowles,
 CP1          80 mg/5 mL,                          Radzius & Rudberry
             Hydrochlorothiazide 25 mg/5 mL
------------------------------------------------------------------------
88P-0011/    Cyclophosphamide 20 mg/mL, 500 mL    Baxter Healthcare
 CP1          pharmacy bulk pack (PBP)             Corp.
------------------------------------------------------------------------
88P-0036/    Chlorhexidine Gluconate 0.5%         Arent, Fox, Kinter,
 CP1                                               Plotkin & Kahn
------------------------------------------------------------------------
88P-0061/    Homatropine Methylbromide 1.5 mg,    Kleinfeld, Kaplan &
 CP1         Hydrocodone Bitartrate 5 mg           Becker
------------------------------------------------------------------------
88P-0149/    Leucovorin Calcium 1 mg/mL           Roxane Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
88P-0277/    Quinidine Sulfate 300 mg             A. H. Robins
 CP1
------------------------------------------------------------------------
88P-0350/    Clemastine Fumarate 1.34 mg,         Scientific Consulting
 CP1         Phenylpropanolamine Hydrochloride     of VA, Inc.
              75 mg
------------------------------------------------------------------------
88P-0379/    Cyclophosphamide 20 mg/mL, 250 mL    Baxter Healthcare
 CP1          PBP                                  Corp.
------------------------------------------------------------------------
88P-0391/    Prednisone 1 mg, 2.5 mg, 5 mg, 10    B.F. Ascher & Co.,
 CP1          mg, 20 mg, 25 mg, or 50 mg           Inc.
------------------------------------------------------------------------
89P-0028/    Hydrocortisone Valerate 0.2%         McKenna, Conner &
 CP1                                               Cuneo
------------------------------------------------------------------------
89P-0029/    Hydrocortisone Valerate 0.2%         Do.
 CP1
------------------------------------------------------------------------
89P-0071/    Morphine Sulfate 30 mg               Ethypharm/Oxford
 CP1                                               Research Intl. Corp.
------------------------------------------------------------------------
89P-0399/    Carbamazepine 200 mg/5 mL            Guidelines, Inc.
 CP1
------------------------------------------------------------------------
89P-0435/    Pentamidine Isethionate 100 mg/mL    Astra Pharmaceutical
 CP1                                               Products, Inc.
------------------------------------------------------------------------
90P-0049/    Hydrocortisone Acetate 2.5% or 1%    Ferndale Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
90P-0084/    Chlorzoxazone 250 mg                 Mikart, Inc.
 CP1
------------------------------------------------------------------------
90P-0154/    Hydrocortisone Acetate 1%            Ferndale Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
90P-0198/    Clobetasol Propionate 0.05%,         Kross, Inc.
 CP1         RLD = Temovate
------------------------------------------------------------------------

[[Page 8187]]

 
90P-0436/    Nifedipine 30 mg, 60 mg, 90 mg       KV Pharmaceutical Co.
 CP1
------------------------------------------------------------------------
91P-0348/    Albuterol Sulfate 4 mg               Richard Hamer
 CP1                                               Associates, Inc.
------------------------------------------------------------------------
92P-0048/    Triazolam 0.125 mg/5 mL              Roxane Laboratories,
 CP2                                               Inc.
------------------------------------------------------------------------
92P-0101/    Hydrocortisone Acetate 2.5%          Hogan & Hartson
 CP1
------------------------------------------------------------------------
92P-0282/    Acetaminophen 150 mg,                Mikart, Inc.
 CP1         Aspirin 180 mg,
             Hydrocodone Bitartrate 5 mg
------------------------------------------------------------------------
92P-0282/    Acetaminophen 150 mg,                Do.
 CP2         Aspirin 180 mg,
             Hydrocodone Bitartrate 7.5 mg
------------------------------------------------------------------------
92P-0282/    Acetaminophen 150 mg,                Do.
 CP3         Aspirin 180 mg,
             Hydrocodone Bitartrate 2.5 mg
------------------------------------------------------------------------
92P-0282/    Acetaminophen 150 mg,                Do.
 CP4         Aspirin 180 mg,
             Hydrocodone Bitartrate 10 mg
------------------------------------------------------------------------
92P-0332/    Propranolol Hydrochloride 40 mg      Flemington
 CP1                                               Pharmaceutical Corp.
------------------------------------------------------------------------
92P-0335/    Albuterol Sulfate 2 mg, 4 mg         WE Pharmaceuticals,
 CP1                                               Inc.
------------------------------------------------------------------------
92P-0336/    Prednisone 5 mg or 10 mg             Do.
 CP1
------------------------------------------------------------------------
92P-0381/    Cytarabine 20 mg/mL, 12.5 mL         Bristol-Myers Squibb
 CP1                                               Co.
------------------------------------------------------------------------
92P-0500/    Timethoprim 25 mg/5 mL               Ascent
 CP1                                               Pharmaceuticals, Inc.
------------------------------------------------------------------------
93P-0048/    Cimetidine 200, 300, 400 or 800 mg   Flemington
 CP1                                               Pharmaceuticals Corp.
------------------------------------------------------------------------
93P-0049/    Propranolol Hydrochloride 10, 20,    Do.
 CP1          60, 80, 90 mg
------------------------------------------------------------------------
93P-0314/    Acetaminophen 500 mg,                Mikart, Inc.
 CP1         Codeine Phosphate 45 mg
------------------------------------------------------------------------
93P-0332/    Loperamide Hydrochloride 1 mg        Asta Medica GmbH
 CP1
------------------------------------------------------------------------
93P-0333/    Prednisone 1, 2.5, 20, 50 mg         Dura Pharmaceuticals
 CP1
------------------------------------------------------------------------
93P-0346/    Acetaminophen 325 mg,                Mikart, Inc.
 CP1         Butalbital 50 mg,
             Caffeine 40 mg,
             Hydrocodone Bitartrate 5 mg
------------------------------------------------------------------------
93P-0367/    Terfenadine 60 mg,                   Eurand America
 CP1         Pseudoephedrine 120 mg
------------------------------------------------------------------------
93P-0446/    Morphine Sulfate 15 mg, 60 mg, 90    Ethypharm
 CP1          mg, 100 mg
------------------------------------------------------------------------
93P-0459/    Methyltestosterone 25 mg             ICN Pharmaceuticals,
 CP1                                               Inc.
------------------------------------------------------------------------
94P-0182/    Acetaminophen 120 mg,                WE Pharmaceuticals,
 CP1         Codeine Phosphate 12 mg               Inc.
------------------------------------------------------------------------
94P-0186/    Sulfamethoxazole 200 mg,             Dura Pharmaceuticals
 CP1         Trimethoprim 40 mg
------------------------------------------------------------------------
94P-0199/    Lorazepam 1 mg/10 mL                 Roxane Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
94P-0210/    Acetaminophen 150 mg,                Mikart, Inc.
 CP1         Aspirin 180 mg,
             Codeine Phosphate 60 mg
------------------------------------------------------------------------
94P-0211/    Acetaminophen 150 mg,                Do.
 CP1         Aspirin 180 mg,
             Codeine Phosphate 30 mg
------------------------------------------------------------------------

[[Page 8188]]

 
94P-0212/    Acetaminophen 150 mg,                Do.
 CP1         Aspirin 180 mg,
             Codeine Phosphate 15 mg
------------------------------------------------------------------------
94P-0263/    Fluorouracil 5%                      Bradley
 CP1                                               Pharmaceuticals, Inc.
------------------------------------------------------------------------
94P-0432/    Methylprednisolone 16 mg, 24 mg, 32  Dura Pharmaceuticals
 CP1          mg
------------------------------------------------------------------------
94P-0433/    Leucovorin Calcium 10 mg/mL 350 mg   Lederle Laboratories
 CP1          vial
------------------------------------------------------------------------
94P-0433/    Leucovorin Calcium 10 mg/mL 5 mL     Do.
 CP2          vial
------------------------------------------------------------------------
95P-0008/    Captopril 25 mg/mL                   Roxane Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
95P-0100/    Carbidopa/Levodopa 25/100 mg, 25/    Athena Neurosciences,
 CP1          250 mg                               Inc.
------------------------------------------------------------------------
95P-0223/    Hydrocortisone Butyrate 0.1%         McKenna & Cuneo,
 CP1                                               L.L.P.
------------------------------------------------------------------------
95P-0268/    Acyclovir Sodium 5 mg/mL             Wilmer, Cutler,
 CP1                                               Pickering
------------------------------------------------------------------------
95P-0277/    Cholestyramine 2 g                   Mayrand
 CP1                                               Pharmaceuticals, Inc.
------------------------------------------------------------------------
95P-0279/    Butalbital 50 mg,                    Mikart, Inc.
 CP1         Acetaminophen 325 mg,
             Caffeine 40 mg,
             Hydrocodone Bitartrate 10 mg
------------------------------------------------------------------------
95P-0279/    Butalbital 50 mg,                    Do.
 CP2         Acetaminophen 325 mg,
             Caffeine 40 mg,
             Hydrocodone Bitartrate 7.5 mg
------------------------------------------------------------------------
95P-0279/    Butalbital 50 mg,                    Do.
 CP3         Acetaminophen 500 mg,
             Caffeine 40 mg,
             Hydrocodone Bitartrate 10 mg
------------------------------------------------------------------------
95P-0279/    Butalbital 50 mg,                    Do.
 CP4         Acetaminophen 500 mg,
             Caffeine 40 mg,
             Hydrocodone Bitartrate 7.5 mg
------------------------------------------------------------------------
95P-0326/    Nifedipine 30 mg, 60 mg, 90 mg       KV Pharmaceutical Co.
 CP1
------------------------------------------------------------------------
95P-0328/    Metronidazole 0.75%                  RNB Pharmaceutical Co.
 CP1
------------------------------------------------------------------------
96P-0018/    Potassium Chloride 20                KV Pharmaceutical Co.
 CP1          milliequivalents (meq)
------------------------------------------------------------------------
96P-0021/    Aspirin 650 mg                       Savage Laboratories,
 CP1         Butalbital 50 mg                      Division of Altana,
                                                   Inc.
------------------------------------------------------------------------
96P-0054/    Potassium Chloride 10 meq            KV Pharmaceutical Co.
 CP1
------------------------------------------------------------------------
96P-0079/    Pentoxyfylline 400 mg                Do.
 CP1
------------------------------------------------------------------------
96P-0307/    Acyclovir 5%                         Pitney, Hardin, Kipp &
 CP1                                               Szuch
------------------------------------------------------------------------
96P-0376/    Hydrocortisone Acetate 90 mg         Do.
 CP1
------------------------------------------------------------------------
96P-0510/    Diltiazem Hydrochloride 120 mg, 180  Labopharm, Inc.
 CP1          mg, 240 mg,
             RLD = Cardiazem CD
------------------------------------------------------------------------
97P-0155/    Mefenamic Acid 250 mg                Pitney, Hardin, Kipp &
 CP1                                               Szuch
------------------------------------------------------------------------
97P-0192/    Diltiazem Hydrochloride 120 mg, 180  Labopharm, Inc.
 CP1          mg, 240 mg,
             RLD = Dilacor XR
------------------------------------------------------------------------
97P-0195/    Diltiazem Hydrochloride 120 mg, 180  Do.
 CP1          mg, 240 mg,
             RLD = Tiazac
------------------------------------------------------------------------
97P-0387/    Albuterol Sulfate 2 mg and 4 mg      Richard Hamer Assoc.,
 CP1                                               Inc.
------------------------------------------------------------------------
97P-0404/    Famotidine 10 mg                     Thomas Blake, R.Ph.
 CP1
------------------------------------------------------------------------

[[Page 8189]]

 
98P-0068/    Clobetasol Propionate 0.05%,         Richard Hamer
 CP1         RLD = Temovate E                      Associates, Inc.
------------------------------------------------------------------------
98P-0146/    Ifosfamide 50 mg/mL, 20 mL, and 60   Mitchall G. Clark
 CP1          mL
------------------------------------------------------------------------
98P-0199/    Captopril 25 mg/5 mL                 Miran Consulting, Inc.
 CP1
------------------------------------------------------------------------
98P-0745/    Econazole Nitrate 1%                 Do.
 CP1
------------------------------------------------------------------------

    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