FDA Drug Approvals List

The FDA Drug Approvals monthly list is provided by DDSA. The Drug approvals on this list are verified and published as they become available and at any given time may not contain all FDA drug approvals.

[Chemical type and therapeutic potential codes are not verified prior to publication].

Updated April 15, 2007

Original Application #: 021216 Approval Date: 12-MAR-07
Trade Name: NEURONTIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: SYRUP Applicant: PARKE DAVIS PHARMACEUTICALS LTD Active Ingredient(s): GABAPENTIN OTC/RX Status: RX Indication(s): As an adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 years and above

Original Application #: 021192 Approval Date: 06-MAR-07
Trade Name: LESCOL XL Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET, EXTENDED RELEASE Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FLUVASTATIN SODIUM OTC/RX Status: RX Indication(s): For the use as an adjunct to diet to reduce elevated total cholesterol (total-C), LDL-C, TG, and Apo B levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate; to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total and LDL cholesterol to target levels

Original Application #: 020874 Approval Date: 05-MAR-07
Trade Name: LUNELLE Chemical Type: 4 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE OTC/RX Status: RX Indication(s): For the prevention of pregnancy

Application #: 020882 Efficacy Supplement#: 012 Type: SE1 to Original New Drug Application Approval Date: 12-MAR-07
Trade Name: NEURONTIN Dosage Form: TABLET Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO Active Ingredient(s): GABAPENTIN OTC/RX Status: RX Efficacy Claim: As an adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 years and above

Application #: 020235 Efficacy Supplement#: 015 Type: SE1 to Original New Drug Application Approval Date: 12-MAR-07
Trade Name: NEURONTIN Dosage Form: CAPSULE Applicant: PARKE DAVIS PHARMACEUTICALS LTD Active Ingredient(s): GABAPENTIN OTC/RX Status: RX Efficacy Claim:As an adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 years and above

Application #: 019901 Efficacy Supplement #: 028 Type: SE1 to Original New Drug Application Approval Date: 04-MAR-07
Trade Name: ALTACE Dosage Form: CAPSULE Applicant: KING PHARMACEUTICALS INC Active Ingredient(s): RAMIPRIL OTC/RX Status: RX Efficacy Claim: For the reduction in risk of myocardial infarction, stroke, and death from cardiovascular causes

Original Abbreviated Application # 075613 Approval Date: 10-MAR-07
Trade Name: BUPROPION HCL Dosage Form: TABLET Applicant: EON LABORATORIES MANUFACTURING INC Active Ingredient(s): BUPROPION HYDROCHLORIDE OTC/RX Status: RX

Original Abbreviated Application # 075468 Approval Date: 06-MAR-07
Trade Name: CLONAZEPAM Dosage Form: TABLET Applicant: TORPHARM INC Active Ingredient(s): CLONAZEPAM OTC/RX Status: RX

Original Abbreviated Application # 075361 Approval Date: 05-MAR-07
Trade Name: ISOSORBIDE MONONITRATE Dosage Form: TABLET Applicant: WESTWARD PHARMACEUTICAL CORP Active Ingredient(s): ISOSORBIDE MONONITRATE OTC/RX Status: RX

Original Abbreviated Application # 040304 Approval Date: 02-MAR-07
Trade Name: OXYCODONE AND ACETAMINOPHEN Dosage Form: CAPSULE Applicant: BARR LABORATORIES INC Active Ingredient(s): ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE OTC/RX Status: RX

Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval Original Abbreviated Application #: 075297 Tentative Approval Date: 10-MAR-07
Trade Name: PACLITAXEL Dosage Form: INJECTABLE Applicant: ZENITH GOLDLINE PHARMACEUTICALS Active Ingredient(s): PACLITAXEL OTC/RX Status: RX

Application #: 018983 Labeling Supplement#: 031 To Original New Drug Application Approval Date: 16-MAR-07 Trade Name: COLYTE Dosage Form: SOLUTION Applicant: SCHWARZ PHARMA INC Active Ingredient(s): SODIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE OTC/RX Status: RX

Application #: 018983 Labeling Supplement#: 030 To Original New Drug Application Approval Date: 16-MAR-07 Trade Name: COLYTE Dosage Form: SOLUTION Applicant: SCHWARZ PHARMA INC Active Ingredient(s): SODIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE OTC/RX Status: RX

Application #: 021129 Labeling Supplement#: 015 To Original New Drug Application Approval Date: 12-MAR-07 Trade Name: NEURONTIN Dosage Form: SOLUTION Applicant: PARKE DAVIS DIV WARNER LAMBERT CO Active Ingredient(s): GABAPENTIN OTC/RX Status: RX

Application #: 019668 Labeling Supplement#: 014 To Original New Drug Application Approval Date: 10-MAR-07 Trade Name: CARDURA Dosage Form: TABLET Applicant: PFIZER LABORATORIES DIV PFIZER INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX

Application #: 020261 Labeling Supplement#: 028 To Original New Drug Application Approval Date: 06-MAR-07 Trade Name: LESCOL Dosage Form: CAPSULE Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FLUVASTATIN SODIUM OTC/RX Status: RX

Application #: 019970 Labeling Supplement#: 011 To Original New Drug Application Approval Date: 06-MAR-07 Trade Name: NITROGLYCERIN IN DEXTROSE 5% Dosage Form: INJECTABLE Applicant: BAXTER HEALTHCARE CORP Active Ingredient(s): NITROGLYCERIN OTC/RX Status: RX

Application #: 020713 Labeling Supplement#: 017 To Original New Drug Application Approval Date: 03-MAR-07 Trade Name: MIRCETTE Dosage Form: TABLET Applicant: ORGANON INC SUB AKZO NOBEL INC Active Ingredient(s): DESOGESTREL; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL OTC/RX Status: RX

Application #: 020607 Labeling Supplement #: 015 To Original New Drug Application Approval Date: 03-MAR-07 Trade Name: ARTHROTEC Dosage Form: TABLET Applicant: GD SEARLE AND CO Active Ingredient(s): DICLOFENAC SODIUM; MISOPROSTOL OTC/RX Status: RX

Application #: 018831 Labeling Supplement #: 022 To Original New Drug Application Approval Date: 03-MAR-07 Trade Name: TRACRIUM PRESERVATIVE FREE Dosage Form: INJECTABLE Applicant: ABBOTT LABORATORIES Active Ingredient(s): ATRACURIUM BESYLATE OTC/RX Status: RX

Application #: 018453 Labeling Supplement#: 019 To Original New Drug Application Approval Date: 02-MAR-07 Trade Name: ANECTINE Dosage Form: INJECTABLE Applicant: GLAXO WELLCOME INC Active Ingredient(s): SUCCINYLCHOLINE CHLORIDE OTC/RX Status: RX

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Definitions Approvable Original New Drug Applications An approvable letter indicates that FDA is prepared to approve the application upon the satisfaction of conditions specified in the approvable letter. Drug products which are the subject of approvable letters may not be legally marketed until the firm has satisfied the identified deficiencies, as well as any other requirements that may be imposed by FDA, and has been notified in writing that the application has been approved. Further information on approvable NDAs is not subject to Freedom of Information (FOI) release until applications are approved. Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval A tentative approval indicates that FDA has given an abbreviated new drug application (ANDA) or 505(b)(2) application provisional approval under the terms of the Drug Price Competition and Patent Term Restoration Act. Such drug products that are the subjects of tentative approvals may not be legally marketed until the market exclusivity and/or patent term of the listed reference drug product has expired. Final approval is also contingent upon conditions and information available to FDA remaining acceptable. When the application receives final approval, the product may be legally marketed. The effective approval date will be listed in this publication and in the " Approved Drug Products with Therapeutic Equivalence Evaluations" list published by FDA. Additional information on these applications will become available to the public when the applications receive final approval. Notes Notes: FDA classifies investigational new drug applications (INDs) and new drug applications (NDAs) to assign review priority on the basis of the drug's chemical type and potential benefit: Chemical Type (CHE) 1. New molecular entity, or NME: An active ingredient that has never been marketed in this country. 2. New derivative: A chemical derived from an active ingredient already marketed (a "parent" drug). 3. New formulation: A new dosageform or new formulation of an active ingredient already on the market. 4. New combination: A drug that contains two or more compounds, the combination of which has not been marketed together in a product. 5. Already marketed drug product but a new manufacturer: A product that duplicates another firm's already marketed drug product: same active ingredient, formulation, or combination. 6. Already marketed drug product, but a new use: A new use for a drug product already marketed by a different firm. 7. Drug already legally marketed without an approved NDA 1 - First post-1962 applications for products marketed prior to 1938 2 - First applications for DESI-related products first marketed between 1938 and 1962 without NDAs 3 - First applications for DESI-related products first marketed after 1962 without NDAs - The indications can be the same or different from the legally marketed product Effectiveness Supplement Code Definitions SE1 A new indication or a significant modification of an existing indication, including removal of a major limitation to use, such as second line status. SE2 A new dosage regimen, including an increase or decrease in daily dosage, or a change in frequency of administration. SE3 A new route of administration. SE4 A comparative efficacy claim naming another drug, including a comparative pharmacokinetic claim. SE5 A change in sections other than the INDICATIONS AND USAGE section that would significantly alter the patient population to be treated, such as addition of pediatric use and/or dosing information or geriatric use and/or dosing information. SE6 An Rx-to-OTC switch. Treatment Potential (TP) P-Priority review drug: A drug that appears to represent an advance over available therapy S-Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug. Other Designations (may apply simultaneously) AA AIDS drug: A drug indicated for treating AIDS or other HIV related disease. E Subpart E drug: A drug developed or evaluated under special procedures for drugs to treat lifethreatening or severely debilitating illnesses. (The name refers to Title 21 of the Code of Federal Regulations, Part 312, Subpart E, which governs this classification.) V Designated orphan drug: A drug for which the sponsor received orphan designation under the Orphan Drug Act. Such a sponsor is eligible for tax credits and exclusive marketing rights for the drug.