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Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
and resultant under-utilization; Form Number: CMS–R–52 (OMB#: 0938– 0386); Frequency: Recordkeeping and Reporting—Annually; Affected Public: Michelle Shortt,
Business or other for-profit and Federal government; Number of Respondents: Director, Regulations Development Group, Office of Strategic Operations and Regulatory 4,757; Total Annual Responses: 4,757; [FR Doc. E6–9479 Filed 6–15–06; 8:45 am] BILLING CODE 4120–01–P
DATES: Effective June 16, 2006.
DEPARTMENT OF HEALTH AND
address at http://www.cms.hhs.gov/ FOR FURTHER INFORMATION CONTACT:
HUMAN SERVICES
PaperworkReductionActof1995, or E- Food and Drug Administration
[Docket No. 2006N–0222]
[email protected], or call the Reports Clearance Office on (410) 786– Merck & Co., Inc., et al.; Withdrawal of
Approval of 65 New Drug Applications
SUPPLEMENTARY INFORMATION: The
and 52 Abbreviated New Drug
holders of the applications listed in the Applications
AGENCY: Food and Drug Administration,
ACTION: Notice.
SUMMARY: The Food and Drug
Vitamin B6 (pyridoxine hydrochloride (HCl)) Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, BLA–20, Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543– Sultrin Triple Sulfa Cream and Triple Sulfa Tablets Ortho-McNeil Pharmaceutical, Inc., 1000 U.S. Highway 202, Lederle Laboratories, 401 North Middleton Rd., Pearl River, NY Rubramin (cyanocobalamin) Tablets and Capsules Aventis Pharmaceuticals, Inc., 200 Crossing Blvd., BX 2–309E, Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, Cortril (hydrocortisone) Topical Ointment Pfizer Global Pharmaceuticals, 235 East 42nd St., New York, Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA Biphetamine (dextroamphetamine and amphetamine) Celltech Pharmaceuticals, Inc., 755 Jefferson Rd., P.O. Box Dimetane (brompheniramine maleate) Tablets and Wyeth Consumer Healthcare, 5 Giralda Farms, Madison, NJ Cerumenex (triethanolamine polypeptide oleate-conden- The Purdue Frederick Co., 1 Stamford Forum, Stamford, CT Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
Aristocort (triamcinolone diacetate) Syrup Astellas Pharma US, Inc., 3 Parkway North, Deerfield, IL 60015– Decadron Phosphate (dexamethasone sodium phos- Robaxisal (methocarbamol USP and aspirin USP) Tab- A.H. Robins Co., c/o Wyeth Pharmaceuticals, P.O. Box 8299, AstraZeneca Pharmaceuticals, 1800 Concord Pike, P.O. Box Periactin (cyproheptadine HCl) Syrup, 2 milligrams (mg)/ Aldomet (methyldopate HCl) Injection, 50 mg/mL Dexacort Phosphate (dexamethasone sodium phos- NDA 16–016 Aldoclor–150 and -250 (methyldopa and chlorothiazide) Tablets, 250 mg/150 mg and 250 mg/250 mg Bayer 8 Hour Aspirin and Measurin Aspirin (aspirin ex- Bayer Healthcare, LLC, 36 Columbia Rd., P.O. Box 1910, Mor- Jergens Antibacterial Deodorant (triclocarban, 1%) Soap Kao Brands Co., 2535 Springs Grove Ave., Cincinnati, OH Selsun Blue (selenium sulfide) Cream/Shampoo, 1% Abbott Laboratories, 625 Cleveland Ave., Columbus, OH 43215– Glenwood LLC, 111 Cedar Lane, Englewood, NJ 07631 Vanceril (beclomethasone dipropionate) Inhalation Aer- Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 Alupent (metaproterenol sulfate) Inhalation Solution, 5% Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877–0368 Diprosone (betamethasone dipropionate) Lotion Dobutrex (dobutamine HCl) Sterile Injection B. Braun Medical, Inc., 2525 McGaw Ave., P.O. Box 19791, 5% Dextrose and 0.9% Sodium Chloride (NaCl) Injection 10% Dextrose and 0.9% NaCl Injection USP 1/6 Molar Sodium Lactate Injection USP in Plastic Con- BASF Corp., 8800 Line Ave., Shreveport, LA 71106 Isolyte S (multi-electrolyte injection) Injection Tonocard (tocainide HCl) Tablets, 400 mg and 600 mg Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
Isolyte S (multi-electrolyte injection) with 5% Dextrose in Aldomet (methyldopa) Oral Suspension, 250 mg/5 mL NDA 18–682 TZ–3 (1% tioconazole) Dermal Cream Pfizer, Inc., 235 East 42nd St., New York, NY 10017 Normodyne (labetalol HCl USP) Injection, 5 mg/mL Orudis (ketoprofen) Capsules, 25 mg, 50 mg, and 75 mg Hospira, Inc., 275 North Field Dr., Dept. 389, Bldg. 2, Lake For- Aminess (essential amino acids injection with histidine) Heparin Sodium in 5% Dextrose Injection and Heparin Genentech, Inc., 1 DNA Way MSι242, South San Francisco, CA Alphatrex (betamethasone dipropionate cream USP) Savage Laboratories, 60 Baylis Rd., Melville, NY 11747 Alphatrex (betamethasone dipropionate ointment USP) Proventil (albuterol sulfate extended-release tablets USP) Schering Corp. NDA 19–401 Pseudo–12 Suspension (pseudoephedrine polistirex ex- Vancenase AQ (beclomethasone dipropionate) Nasal GlaxoSmithKline Pharmaceuticals, 5 More Dr., P.O. Box 13358, Johnson & Johnson Pharmaceutical Research and Develop- ment, LLC, c/o Janssen Pharmaceutical Products, LP, 1125 Trenton-Harbourton Rd., K1–02B, Titusville, NJ 08560–0200 Galderma Laboratories, LP, 14501 North Freeway, Fort Worth, Trovan (trovafloxacin mesylate) Tablets, 100 mg and 200 Pfizer, Inc. Trovan (alatrofloxacin mesylate) Injection Esclim (estradiol extended-release film) Transdermal Women First Healthcare, Inc., 380 Lexington Ave., New York, Emla (2.5% lidocaine and 2.5% prilocaine) Anesthetic Adrucil (fluorouracil injection USP), 50 mg/mL Sicor Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618 Leucovorin Calcium Injection USP, 10 mg (base)/mL Garamycin (gentamicin sulfate) Ophthalmic Solution Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
Chloroptic (chloramphenicol ophthalmic solution USP), Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA Neodecadron (neomycin sulfate and dexamethasone so- dium phosphate) Sterile Ophthalmic Solution Ilotycin (erythromycin) Ophthalmic Ointment TAP Pharmaceutical Products, Inc., 675 North Field Dr., Lake Clindamycin Phosphate Injection in 5% Dextrose Baxter Healthcare Corp., Route 120 & Wilson Rd., Round Lake, Sumycin Capsules (tetracycline HCl capsules USP) Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Gentacidin Solution (gentamicin sulfate ophthalmic solu- Novartis Pharmaceuticals Corp., 1 Health Plaza, Bldg. 118, East Mytrex (nystatin and triamcinolone acetonide cream Mytrex (nystatin and triamcinolone acetonide ointment Pipracil (piperacillin for injection), 2 g, 3 g, and 4 g Cephalexin Capsules USP, 250 mg and 500 mg Sterile Bleomycin Sulfate for Injection USP, 15 and 30 Alphatrex (betamethasone dipropionate lotion USP), Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH Metoclopramide HCl Oral Solution, 10 mg/mL Toposar (etoposide injection USP), 20 mg/mL Cimetidine HCl Oral Solution, 30 mg/5 mL Acyclovir Sodium for Injection USP, 500 mg base/vial Copley Pharmaceutical, Inc., 1090 Horsham Rd., P.O. Box 1090, Carbamazepine Oral Suspension USP, 100 mg/5 mL Taro Pharmaceutical Industries, Ltd., c/o Taro Pharmaceuticals, U.S. Agent, 5 Skyline Dr., Hawthorne, NY 10532 Diphenhydramine HCl Elixir USP, 25 mg/10 mL Adrucil (etopside injection USP), 50 mg/mL Diucardin (hydroflumethiazide tablets USP) Tablets, 50 Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
ANDA 84–015 Bleph–10 (sulfacetamide sodium ophthalmic ointment ANDA 84–751 Dilor–400 (dyphylline tablets USP), 400 mg Diphenoxylate HCl and Atropine Sulfate Tablets USP, R & S Pharma, LLC, 8407 Austin Tracy Rd., Fountain Run, KY Clonmel Healthcare Ltd., c/o STADA Pharmaceuticals, Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512 Isoetharine HCl Inhalation Solution USP, 1% T-Phyl (theophylline) Extended-Release Tablets, 200 mg Therefore, under section 505(e), of the Department of Commerce, for the ADDRESSES: Submit written comments
and petitions to the Division of Dockets Management (HFA–305), Food and Drug toward the actual amount of extension approval of the applications listed in the Administration, 5630 Fishers Lane, rm. subtracted, as well as any time that may FOR FURTHER INFORMATION CONTACT:
issued), FDA’s determination of the length of a regulatory review period for Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation [FR Doc. E6–9440 Filed 6–15–06; 8:45 am] SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
BILLING CODE 4160–01–S
Restoration Act of 1984 (Public Law 98– the human drug product INSPRA 417) and the Generic Animal Drug and DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E–0254]
Novartis Corp., and the Patent and Trademark Office requested FDA’s Determination of Regulatory Review
assistance in determining this patent’s Period for Purposes of Patent
eligibility for patent term restoration. In Extension; INSPRA
item was marketed. Under these acts, a product’s regulatory review period AGENCY: Food and Drug Administration,
Office that this human drug product had undergone a regulatory review period ACTION: Notice.
A regulatory review period consists of and that the approval of INSPRA SUMMARY: The Food and Drug
two periods of time: A testing phase and represented the first permitted the regulatory review period for INSPRA products, the testing phase begins when FDA determine the product’s regulatory

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