|
Drug Approvals for March 2002
Definitions and Notes
Original New Drug Applications
Original Application #: 020855
Approval Date: 21-MAR-02
Trade Name: MESNA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ASTA MEDICA AG
Active Ingredient(s): MESNA
OTC/RX Status: RX
Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis
Original Application #: 021260
Approval Date: 20-MAR-02
Trade Name: AVINZA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORP
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX
Indication(s): For the relief of moderate to severe pain requiring continuous around-the-clock opioid therapy for an extended period of time
Original Application #: 021113
Approval Date: 04-MAR-02
Trade Name: PAMIDRONATE DISODIUM INJECTION
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX
Indication(s): For the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases, for the treatment of patients with moderate to severe Paget's disease of bone, and for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma in conjunction with standard antineoplastic therapy
Original Application #: 021342
Approval Date: 01-MAR-02
Trade Name: LEVO-T
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: MOVA PHARMACEUTICALL CORPORATION
Active Ingredient(s): LEVOTHYROXINE SODIUM
OTC/RX Status: RX
Indication(s): For the treatment of hypothyroidism and suppression of thyroid-stimulating hormone
Efficacy Supplemental New Drug Applications
Application #: 020412 Efficacy Supplement #: 016
Type: SE8 to Original New Drug Application
Approval Date: 29-MAR-02
Trade Name: ZERIT
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): STAVUDINE
OTC/RX Status: RX
Efficacy Claim: For use in pediatric patients from birth to five weeks
Application #: 020413 Efficacy Supplement #: 007
Type: SE8 to Original New Drug Application
Approval Date: 29-MAR-02
Trade Name: ZERIT
Dosage Form: SOLUTION
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): STAVUDINE
OTC/RX Status: RX
Efficacy Claim: For use in pediatric patients from birth to five weeks
Application #: 020933 Efficacy Supplement#: 007
Type: SE7 to Original New Drug Application
Approval Date: 27-MAR-02
Trade Name: VIRAMUNE
Dosage Form: SOLUTION
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX
Efficacy Claim: In combination with other antiretroviral agents for the treatment of HIV-1 infection
Application #: 020636 Efficacy Supplement#: 017
Type: SE7 to Original New Drug Application
Approval Date: 27-MAR-02
Trade Name: VIRAMUNE
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX
Efficacy Claim:In combination with other antiretroviral agents for the treatment of HIV-1 infection
Application #: 020692 Efficacy Supplement#: 016
Type: SE1 to Original New Drug Application
Approval Date: 22-MAR-02
Trade Name: SEREVENT
Dosage Form: POWDER, FOR INHALATION
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX
Efficacy Claim: For the long=term, twice-daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with COPD (including emphysema and chronic bonchitis)
Application #: 020150 Efficacy Supplement#: 011
Type: SE6 to Original New Drug Application
Approval Date: 21-MAR-02
Trade Name: NICOTROL
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: PHARMACIA AND UPJOHN CONSUMER HEALTHCARE
Active Ingredient(s): NICOTINE
OTC/RX Status: RX
Efficacy Claim: For the Over-the-Counter (OTC) marketing of Nicotrol TD step-down regimen for adults 18 years of age and older, to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking
Application #: 020744 Efficacy Supplement#: 004
Type: SE8 to Original New Drug Application
Approval Date: 01-MAR-02
Trade Name: CUROSURF
Dosage Form: SUSPENSION
Applicant: DEY, LP
Active Ingredient(s): PORACTANT ALFA
OTC/RX Status: RX
Efficacy Claim: For the treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants
Approvable Original New Drug Applications
Original Abbreviated Application # 040398
Approval Date: 29-MAR-02
Trade Name: MICORT-HC LIPOCREAM
Dosage Form: CREAM
Applicant: FERNDALE LABORATORIES, INC
Active Ingredient(s): HYDROCORTISONE ACETATE
OTC/RX Status: RX
Original Abbreviated Application # 040412
Approval Date: 29-MAR-02
Trade Name: HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS, INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Original Abbreviated Application # 076153
Approval Date: 27-MAR-02
Trade Name: PAMIDRONATE DISODIUM
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX
Original Abbreviated Application # 076264
Approval Date: 22-MAR-02
Trade Name: NALTREXONE HCL
Dosage Form: TABLET
Applicant: MALLINCKRODT INC
Active Ingredient(s): NALTREXONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075803
Approval Date: 20-MAR-02
Trade Name: LEVONORGESTREL AND ETHINYL ESTRADIOL
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): ETHINYL ESTRADIOL;LEVONORGESTREL
OTC/RX Status: RX
Original Abbreviated Application # 076200
Approval Date: 19-MAR-02
Trade Name: ACETAMINOPHEN
Dosage Form: TABLET,EXTENDED RELEASE
Applicant: COREPHARMA LLC
Active Ingredient(s): ACETAMINOPHEN
OTC/RX Status: OTC
Original Abbreviated Application # 075860
Approval Date: 19-MAR-02
Trade Name: DESONIDE
Dosage Form: LOTION
Applicant: ALTANA INC
Active Ingredient(s): DESONIDE
OTC/RX Status: RX
Original Abbreviated Application # 075413
Approval Date: 19-MAR-02
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 065076
Approval Date: 19-MAR-02
Trade Name: AMPICILLIN SODIUM AND SULBACTAM SODIUM
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): SULBACTAM SODIUM; AMPICILLIN SODIUM
OTC/RX Status: RX
Original Abbreviated Application # 076067
Approval Date: 18-MAR-02
Trade Name: MOMETASONE FUROATE
Dosage Form: OINTMENT
Applicant: CLAY PARK LABORATORIES INC
Active Ingredient(s): MOMETASONE FUROATE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 065009
Approval Date: 18-MAR-02
Trade Name: ERYTHROMYCIN
Dosage Form: GEL
Applicant: GLADES PHARMACEUTICALS INC
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX
Original Abbreviated Application # 040431
Approval Date: 18-MAR-02
Trade Name: FLUDROCORTISONE ACETATE
Dosage Form: TABLET
Applicant: IMPAX LABORATORIES INC
Active Ingredient(s): FLUDROCORTISONE ACETATE
OTC/RX Status: RX
Original Abbreviated Application # 076058
Approval Date: 15-MAR-02
Trade Name: MIDAZOLAM HCL
Dosage Form: SYRUP
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075737
Approval Date: 15-MAR-02
Trade Name: MINOXIDIL
Dosage Form: SOLUTION
Applicant: CLAY PARK LABORATORIES INC
Active Ingredient(s): MINOXIDIL
OTC/RX Status: OTC
Original Abbreviated Antibiotic Application# 065064
Approval Date: 15-MAR-02
Trade Name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Original Abbreviated Application # 075995
Approval Date: 14-MAR-02
Trade Name: IBUPROFEN
Dosage Form: TABLET
Applicant: L PERRIGO CO
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Original Abbreviated Application # 075119
Approval Date: 14-MAR-02
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: EGIS PHARMACEUTICALS
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 065063
Approval Date: 14-MAR-02
Trade Name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Original Abbreviated Application # 075824
Approval Date: 12-MAR-02
Trade Name: BUTORPHANOL
Dosage Form: SPRAY, METERED
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX
Original Abbreviated Application # 075610
Approval Date: 12-MAR-02
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC
Original Abbreviated Application# 075385
Approval Date: 01-MAR-02
Trade Name: BUSPIRONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS, INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 075400
Tentative Approval Date: 25-MAR-02
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: L PERRIGO CO
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application #: 074732
Tentative Approval Date: 21-MAR-02
Trade Name:TAMOXIFEN CITRATE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX
Original Abbreviated Application #: 074539
Tentative Approval Date: 21-MAR-02
Trade Name:TAMOXIFEN CITRATE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 050750 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 27-MAR-02
Trade Name: ZOSYN
Dosage Form: INJECTABLE
Applicant:WYETH-AYERST RESEARCH
Active Ingredient(s): TAZOBACTAM SODIUM; PIPERACILLIN SODIUM
OTC/RX Status: RX
Application #: 050684 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 27-MAR-02
Trade Name: ZOSYN
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): TAZOBACTAM SODIUM; PIPERACILLIN SODIUM
OTC/RX Status: RX
Application #: 018017 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 27-MAR-02
Trade Name: BLOCADREN
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Application #: 050632 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 25-MAR-02
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX
Application #: 050580 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 25-MAR-02
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX
Application #: 050634 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 22-MAR-02
Trade Name: FORTAZ
Dosage Form: INJECTABLE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): CEFTAZIDIME SODIUM
OTC/RX Status: RX
Application #: 050578 Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 22-MAR-02
Trade Name: FORTAZ
Dosage Form: INJECTABLE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): CEFTAZIDIME
OTC/RX Status: RX
Application #: 020624 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 22-MAR-02
Trade Name: ANZEMET
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): DOLASETRON MESYLATE MONOHYDRATE
OTC/RX Status: RX
Application #: 019779 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 22-MAR-02
Trade Name: IOPIDINE
Dosage Form: SOLUTION
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): APRACLONIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 017874 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 22-MAR-02
Trade Name: TRANSDERM SCOP
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVARTIS CONSUMER HEALTH INC
Active Ingredient(s): SCOPOLAMINE
OTC/RX Status: RX
Application #: 017029 Labeling Supplement#: 099
To Original New Drug Application
Approval Date: 22-MAR-02
Trade Name: HEPARIN SODIUM
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX
Application #: 009053 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 22-MAR-02
Trade Name: PURINETHOL
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): MERCAPTOPURINE
OTC/RX Status: RX
Application #: 050753 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 21-MAR-02
Trade Name: TOBI
Dosage Form: SOLUTION, FOR INHALATION
Applicant: CHIRON CORP
Active Ingredient(s): TOBRAMYCIN
OTC/RX Status: RX
Application #: 050641 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 21-MAR-02
Trade Name: MONODOX
Dosage Form: CAPSULE
Applicant: OCLASSEN PHARMACEUTICALS INC
Active Ingredient(s): DOXYCYCLINE
OTC/RX Status: RX
Application #: 018201 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 21-MAR-02
Trade Name: MODURETIC 5-50
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Application #: 018200 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 21-MAR-02
Trade Name: MIDAMOR
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): AMILORIDE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018771 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 20-MAR-02
Trade Name: LACRISERT
Dosage Form: SUPPOSITORY, INSERT
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): HYDROXYPROPYL CELLULOSE
OTC/RX Status: RX
Application #: 017714 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 20-MAR-02
Trade Name: AN-DTPA
Dosage Form: INJECTABLE
Applicant: CIS US INC
Active Ingredient(s): TECHNETIUM TC-99M PENTETATE KIT
OTC/RX Status: RX
Application #: 020204 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 19-MAR-02
Trade Name: ALEVE
Dosage Form: TABLET
Applicant: BAYER CORP CONSUMER CARE DIV
Active Ingredient(s): NAPROXEN
OTC/RX Status: OTC
Application #: 050658 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 18-MAR-02
Trade Name: TIMENTIN
Dosage Form: INJECTABLE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): TICARCILLIN DISODIUM; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application #: 050590 Labeling Supplement#: 040
To Original New Drug Application
Approval Date: 18-MAR-02
Trade Name: TIMENTIN
Dosage Form: POWDER, FOR INJECTION SOLUTION
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): TICARCILLIN DISODIUM; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application #: 017831 Labeling Supplement#: 052
To Original New Drug Application
Approval Date: 15-MAR-02
Trade Name: DIDRONEL
Dosage Form: TABLET
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC
Active Ingredient(s): ETIDRONATE DISODIUM
OTC/RX Status: RX
Application #: 020458 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 14-MAR-02
Trade Name: GALZIN
Dosage Form: CAPSULE
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): ZINC ACETATE
OTC/RX Status: RX
Application #: 018897 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 14-MAR-02
Trade Name: SODIUM CHLORIDE IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): SODIUM CHLORIDE
OTC/RX Status: RX
Application #: 018892 Labeling Supplement #: 021
To Original New Drug Application
Approval Date: 14-MAR-02
Trade Name: SODIUM PHOSPHATES IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
OTC/RX Status: RX
Application #: 020747 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 12-MAR-02
Trade Name: ACTIQ
Dosage Form: TABLET
Applicant: ANESTA CORP
Active Ingredient(s): FENTANYL CITRATE
OTC/RX Status: RX
Application #: 019032 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 12-MAR-02
Trade Name: TENEX
Dosage Form: TABLET
Applicant: A.H. ROBBINS
Active Ingredient(s): GUANFACINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019032 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 12-MAR-02
Trade Name: TENEX
Dosage Form: TABLET
Applicant: A.H. ROBBINS
Active Ingredient(s): GUANFACINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019991 Labeling Supplement #: 032
To Original New Drug Application
Approval Date: 11-MAR-02
Trade Name: NOVOLIN 70/30
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICALS INC
Active Ingredient(s): INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHAN E RECOMBINANT HUMAN
OTC/RX Status: OTC
Application #: 019959 Labeling Supplement #: 031
To Original New Drug Application
Approval Date: 11-MAR-02
Trade Name: NOVOLIN N
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICALS INC
Active Ingredient(s): INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
OTC/RX Status: OTC
Application #: 019938 Labeling Supplement #: 030
To Original New Drug Application
Approval Date: 11-MAR-02
Trade Name: NOVOLIN R
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICALS INC
Active Ingredient(s): INSULIN RECOMBINANT HUMAN
OTC/RX Status: OTC
Application #: 020903 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 06-MAR-02
Trade Name: REBETOL
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH RESEARCH INSTITUTE
Active Ingredient(s): RIBAVIRIN
OTC/RX Status: RX
Application #: 020671 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 06-MAR-02
Trade Name: HYCAMTIN
Dosage Form: INJECTABLE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): TOPOTECAN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020075 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 06-MAR-02
Trade Name: LIORESAL
Dosage Form: INJECTABLE
Applicant: MEDTRONIC INC
Active Ingredient(s): BACLOFEN
OTC/RX Status: RX
Application #: 020075 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 06-MAR-02
Trade Name: LIORESAL
Dosage Form: INJECTABLE
Applicant: MEDTRONIC INC
Active Ingredient(s): BACLOFEN
OTC/RX Status: RX
Application #: 019962 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 05-MAR-02
Trade Name: TOPROL-XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ASTRAZENECA LP
Active Ingredient(s): METOPROLOL SUCCINATE
OTC/RX Status: RX
Application #: 020262 Labeling Supplement #: 038
To Original New Drug Application
Approval Date: 04-MAR-02
Trade Name: TAXOL
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX
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
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.
SE7 Supplement-Accelerated Approval
SE8 Efficacy Supplement with Clinical Data to Support Labeling Claim
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. Also see, "The Evolution of U.S. Drug Law," page 26 of the booklet,  From Test Tube to Patient: NEW DRUG DEVELOPMENT IN THE UNITED STATES.)
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.
 Back
to Top 
Back to Drug Approvals List
Date created: December 07, 2001; last updated: June 20, 2005 |
