Drug Approvals for February 2002

Definitions and Notes

Original New Drug Applications

Original Application #: 020982
Approval Date: 12-FEB-02
Trade Name: PAXIL CR
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of Panic Disorder

Original Application #: 021363
Approval Date: 08-FEB-02
Trade Name: CLARINEX
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SCHERING
Active Ingredient(s): DESLORATADINE
OTC/RX Status: RX
Indication(s): For the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older

Original Application #: 021297
Approval Date: 08-FEB-02
Trade Name: CLARINEX
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SCHERING CORP
Active Ingredient(s): DESLORATADINE
OTC/RX Status: RX
Indication(s): For the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idipathic urticaria 12 years of age and older

Original Application #: 021360
Approval Date: 01-FEB-02
Trade Name: SUSTIVA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB PHARMA CO
Active Ingredient(s): EFAVIRENZ
OTC/RX Status: RX
Indication(s): For the treatment of HIV-1 infection in combination with other antiretrovial agents

Efficacy Supplemental New Drug Applications

Application #: 019643 Efficacy Supplement#: 067
Type: SE5 to Original New Drug Application
Approval Date: 14-FEB-02
Trade Name: MEVACOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of heterozygous familial hypercholesterolemia in a new population of adolescent boys and girls at leat one year postmenarchal, ages 10 to 17 years, with a recommended dosing range of 10 to 40 mg once daily

Application #: 019810 Efficacy Supplement#: 061
Type: SE8 to Original New Drug Application
Approval Date: 14-FEB-02
Trade Name: PRILOSEC
Dosage Form: CAPSULE
Applicant: ASTRAZENECA LP
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX
Efficacy Claim: For the short-term treatment of active duodenal ulcer

Application #: 020811 Efficacy Supplement #: 003
Type: SE5 to Original New Drug Application
Approval Date: 08-FEB-02
Trade Name: ACULAR PRESERVATIVE FREE
Dosage Form: SOLUTION
Applicant: ALLERGAN INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Efficacy Claim: For the temporary relief of ocular itching due to seasonal allergic conjunctivitis; for the treatment of postoperative inflammation in patients who have undergone cataract extraction

Application #: 019700 Efficacy Supplement #: 019
Type: SE5 to Original New Drug Application
Approval Date: 08-FEB-02
Trade Name: ACULAR
Dosage Form: SOLUTION
Applicant: ALLERGAN INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Efficacy Claim:For the temporary relief of ocular itching due to seasonal allergic conjunctivitis; for the treatment of postoperative inflammation in patients who have undergone cataract extraction

Application #: 020582 Efficacy Supplement #: 006
Type: SE1 to Original New Drug Application
Approval Date: 07-FEB-02
Trade Name: FOLLISTIM
Dosage Form: INJECTABLE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): FOLLITROPIN ALFA/BETA
OTC/RX Status: RX
Efficacy Claim: For the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure

Application #: 021007 Efficacy Supplement #: 010
Type: SE8 to Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: AGENERASE
Dosage Form: CAPSULE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX
Efficacy Claim:For the treatment of HIV-1 infection

Application #: 021039 Efficacy Supplement #: 010
Type: SE8 to Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: AGENERASE
Dosage Form: SOLUTION
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX
Efficacy Claim:For the treatment of HIV-1 infection

Approvable Original New Drug Applications

Original Application #: 021269
Approvable Date: 22-FEB-02
Trade Name: CARDURA XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PFIZER INC
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application# 075865
Approval Date: 28-FEB-02
Trade Name: FLUOXETINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant:ZENITH GOLDINE PHARMACEUTICALS INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application# 075022
Approval Date: 28-FEB-02
Trade Name: BUSPIRONE HYDROCHOLORIDE
Dosage Form: TABLET
Applicant:TEVA PHARMACEUTICALS USA
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075948
Approval Date: 27-FEB-02
Trade Name: CARBAMAZEPINE
Dosage Form: TABLET
Applicant: APOTEX INC
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 075572
Approval Date: 27-FEB-02
Trade Name: BUSPIRONE HYDROCHOLORIDE
Dosage Form: TABLET
Applicant: KV PHARMACEUTICAL CO.
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application#065022
Approval Date: 27-FEB-02
Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE
Dosage Form: OINTMENT
Applicant: ALTANA INC
Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE
OTC/RX Status: RX

Original Abbreviated Application# 075874
Approval Date: 26-FEB-02
Trade Name: IFOSFAMIDE INJECTION/MESNA INJECTION KIT
Dosage Form: INJECTABLE
Applicant: GENSIA PHARMACEUTICALS INC
Active Ingredient(s): IFOSFAMIDE; MESNA
OTC/RX Status: RX

Original Abbreviated Application # 075590
Approval Date: 25-FEB-02
Trade Name: NABUMETONE
Dosage Form: TABLET, FILM COATED
Applicant: INVAMED INC
Active Ingredient(s): NABUMETONE
OTC/RX Status: RX

Original Abbreviated Application # 075280
Approval Date: 25-FEB-02
Trade Name: NABUMETONE
Dosage Form: TABLET, FILM COATED
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): NABUMETONE
OTC/RX Status: RX

Original Abbreviated Application #: 075868
Tentative Approval Date: 20-FEB-02
Trade Name: FENOFIBRATE
Dosage Form: CAPSULE
Applicant: IMPAX LABORATORIES INC
Active Ingredient(s): FENOFIBRATE
OTC/RX Status: RX

Original Abbreviated Application # 076165
Approval Date: 15-FEB-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: RANBAXY LABORATORIES LIMITED
Active Ingredient(s): FLUOXETINE
OTC/RX Status: RX

Original Abbreviated Application # 075292
Approval Date: 07-FEB-02
Trade Name: FLUOXETINE HCL
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075364
Approval Date: 07-FEB-02
Trade Name: KETOPROFEN
Dosage Form: TABLET
Applicant: PERRIGO CO
Active Ingredient(s): KETOPROFEN
OTC/RX Status: OTC

Original Abbreviated Application # 076114
Approval Date: 06-FEB-02
Trade Name: INDOMETHACIN
Dosage Form: CAPSULE
Applicant: ABLE LABORATORIES INC
Active Ingredient(s): INDOMETHACIN
OTC/RX Status: RX

Original Abbreviated Application # 076097
Approval Date: 06-FEB-02
Trade Name: CARTEOLOL HCL
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): CARTEOLOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040428
Approval Date: 05-FEB-02
Trade Name: PROMETHAZINE HCL
Dosage Form: SUPPOSITORY
Applicant: G AND W LABORATORIES INC
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040321
Approval Date: 05-FEB-02
Trade Name: METHYLPHENIDATE HCL
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075810
Approval Date: 01-FEB-02
Trade Name: FLUOXETINE HCL
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval

Original Abbreviated Application# 076153
Tentative Approval Date: 28-FEB-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# 075873
Tentative Approval Date: 25-FEB-02
Trade Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form: SYRUP
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application# 076154
Tentative Approval Date: 28-FEB-02
Trade Name: LORATADINE
Dosage Form: TABLET
Applicant:GENPHARM INC
Active Ingredient(s): LORATADINE
OTC/RX Status: RX

Original Abbreviated Application #: 076059
Tentative Approval Date: 05-FEB-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application #: 075928
Tentative Approval Date: 04-FEB-02
Trade Name: CIPROFLOXACIN HCL
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 076067
Tentative Approval Date: 01-FEB-02
Trade Name: MOMETASONE FUROATE
Dosage Form: OINTMENT
Applicant: CLAY-PARK LABS, INC
Active Ingredient(s): MOMETASONE FUROATE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020825 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 15-FEB-02
Trade Name: GEODON
Dosage Form: CAPSULE
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): ZIPRASIDONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019880 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 14-FEB-02
Trade Name: PARAPLATIN
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CARBOPLATIN
OTC/RX Status: RX

Application #: 016267 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 14-FEB-02
Trade Name: DESFERAL
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): DEFEROXAMINE MESYLATE
OTC/RX Status: RX

Application #: 020936 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 12-FEB-02
Trade Name: PAXIL CR
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017936 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 11-FEB-02
Trade Name: NPH ILETIN I INSULIN
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN SUSP ISOPHANE BEEF/PORK
OTC/RX Status: OTC

Application #: 017933 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 11-FEB-02
Trade Name: LENTE ILETIN I INSULIN
Dosage Form: INJECTABLE
Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO
Active Ingredient(s): INSULIN ZINC SUSP BEEF/PORK
OTC/RX Status: OTC

Application #: 017931 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 11-FEB-02
Trade Name: REGULAR ILETIN I
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN PORK
OTC/RX Status: RX

Application #: 016636 Labeling Supplement#: 054
To Original New Drug Application
Approval Date: 11-FEB-02
Trade Name: NARCAN
Dosage Form: INJECTABLE
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): NALOXONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016636 Labeling Supplement#: 052
To Original New Drug Application
Approval Date: 11-FEB-02
Trade Name: NARCAN
Dosage Form: INJECTABLE
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): NALOXONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 021165 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 08-FEB-02
Trade Name: CLARINEX
Dosage Form: TABLET
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): DESLORATADINE
OTC/RX Status: RX

Application #: 021018 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 08-FEB-02
Trade Name: HUMALOG MIX 50/50
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN LISPRO PROTAMINE; INSULIN LISPRO
OTC/RX Status: RX

Application #: 021017 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 08-FEB-02
Trade Name: HUMALOG MIX 75/25
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN LISPRO PROTAMINE; INSULIN LISPRO
OTC/RX Status: RX

Application #: 020793 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 08-FEB-02
Trade Name: CAFCIT
Dosage Form: SOLUTION
Applicant: OPR DEVELOPMENT LP
Active Ingredient(s): CAFFEINE CITRATE
OTC/RX Status: RX

Application #: 018731 Labeling Supplement #: 046
To Original New Drug Application
Approval Date: 07-FEB-02
Trade Name: BUSPAR
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017105 Labeling Supplement #: 062
To Original New Drug Application
Approval Date: 07-FEB-02
Trade Name: TRANXENE
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLORAZEPATE DIPOTASSIUM
OTC/RX Status: RX

Application #: 017105 Labeling Supplement #: 059
To Original New Drug Application
Approval Date: 07-FEB-02
Trade Name: TRANXENE
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLORAZEPATE DIPOTASSIUM
OTC/RX Status: RX

Application #: 016087 Labeling Supplement #: 081
To Original New Drug Application
Approval Date: 07-FEB-02
Trade Name: VALIUM
Dosage Form: INJECTABLE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): DIAZEPAM
OTC/RX Status: RX

Application #: 016087 Labeling Supplement #: 079
To Original New Drug Application
Approval Date: 07-FEB-02
Trade Name: VALIUM
Dosage Form: INJECTABLE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): DIAZEPAM
OTC/RX Status: RX

Application #: 013263 Labeling Supplement #: 075
To Original New Drug Application
Approval Date: 07-FEB-02
Trade Name: VALIUM
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): DIAZEPAM
OTC/RX Status: RX

Application #: 013263 Labeling Supplement #: 072
To Original New Drug Application
Approval Date: 07-FEB-02
Trade Name: VALIUM
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): DIAZEPAM
OTC/RX Status: RX

Application #: 010909 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 06-FEB-02
Trade Name: MIRADON
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): ANISINDIONE
OTC/RX Status: RX

Application #: 021039 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: AGENERASE
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX

Application #: 021007 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: AGENERASE
Dosage Form: CAPSULE, SOFT GELATIN
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX

Application #: 020779 Labeling Supplement #: 038
To Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: VIRACEPT
Dosage Form: TABLET
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX

Application #: 020778 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: VIRACEPT
Dosage Form: POWDER, FOR SUSPENSION
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX

Application #: 020578 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: ZOLADEX
Dosage Form: PELLET, IMPLANT
Applicant: ASTRAZENECA UK LTD
Active Ingredient(s): GOSERELIN ACETATE
OTC/RX Status: RX

Application #: 020484 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: INNOHEP
Dosage Form: INJECTION
Applicant: BRISTOL MYERS SQUIBB PHARMA CO
Active Ingredient(s): TINZAPARIN SODIUM
OTC/RX Status: RX

Application #: 019726 Labeling Supplement #: 034
To Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: ZOLADEX
Dosage Form: IMPLANT
Applicant: ASTRAZENECA UK LTD
Active Ingredient(s): GOSERELIN ACETATE
OTC/RX Status: RX

Application #: 019357 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: ETHAMOLIN
Dosage Form: INJECTABLE
Applicant: QUESTCOR PHARMACEUTICALS INC
Active Ingredient(s): ETHANOLAMINE OLEATE
OTC/RX Status: RX

Application #: 017037 Labeling Supplement #: 146
To Original New Drug Application
Approval Date: 05-FEB-02
Trade Name: HEPARIN SODIUM
Dosage Form: INJECTABLE
Applicant: ELKINS SINN DIV AH ROBINS CO INC
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX

Application #: 020476 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 04-FEB-02
Trade Name: MOTRIN
Dosage Form: DROPS
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Application #: 020418 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 04-FEB-02
Trade Name: MOTRIN
Dosage Form: TABLET
Applicant: MCNEIL CONSUMER HEALTHCARE
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Application #: 020353 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 04-FEB-02
Trade Name: NAPRELAN
Dosage Form: TABLET, CONTROLLED RELEASE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORP
Active Ingredient(s): NAPROXEN SODIUM
OTC/RX Status: RX

Application #: 020135 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 04-FEB-02
Trade Name: MOTRIN
Dosage Form: TABLET, CHEWABLE
Applicant: MCNEIL CONSUMER HEALTHCARE
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Application #: 019842 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 04-FEB-02
Trade Name: MOTRIN
Dosage Form: SUSPENSION
Applicant: MCNEIL CONSUMER HEALTHCARE
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Application #: 012003 Labeling Supplement #: 024
To Original New Drug Application
Approval Date: 04-FEB-02
Trade Name: AKINETON
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): BIPERIDEN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050649 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 01-FEB-02
Trade Name: MINOCIN
Dosage Form: CAPSULE
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): MINOCYCLINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050649 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 01-FEB-02
Trade Name: MINOCIN
Dosage Form: CAPSULE
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): MINOCYCLINE HYDROCHLORIDE
OTC/RX Status: RX

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.

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.