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Journal of Drugs in Dermatology, August, 2003

New Drug Application 9-048/S-037

Approval Date:       3/26/03
Name:                8-MOP (methoxsalen)
                     Capsules
Applicant:           ICN Pharmaceuticals
OTC/RX status:       RX

Indication/Updated labeling information: This supplemental
new drug application provides updated
information about the risk of melanoma for patients
receiving PUVA therapy.

Abbreviated New Drug Application 76-065

Approval Date:       5/15/03
Name:                Amcinonide Cream, 0.1%
Applicant:           Altana, Inc
OTC/RX status:       RX

Indication: Topical steroids are used for the treatment
of mild to moderate inflammatory skin conditions.

Abbreviated New Drug Application 76-367

Approval Date:       3/19/03
Name:                Amcinonide Ointment, 0.1%
Applicant:           Altana, Inc
OTC/RX status:       RX

Indication: Topical steroids are used for the treatment
of mild to moderate inflammatory skin conditions.

Abbreviated New Drug Application 75-883

Approval Date:       4/10/03
Name:                Ammonium Lactate Cream, 12%
Applicant:           Taro Pharmaceuticals
OTC/RX status:       RX
Indication:          For the treatment of xerosis and ichthyosis.

New Drug Application/Supplemental 50-557/S25

Approval Date:       1/27/03
Name:                Benzamycin Topical Gel
Active Ingredients:  Erythromycin 3% and
                     Benzoyl Peroxide 5%
Applicant:           Dermik Laboratories, Inc
OTC/RX status:       RX

Indication: Supplemental new drug application provides
for the replacement of the excipient Carbomer
940NF with the chemically equivalent Carbomer
980.

New Drug Application 21-588

Approval Date:       4/18/03
Name:                Gleevec
Applicant:           Novartis Pharmaceuticals Corp
Active Ingredient:   Imatinib Mesylate
New Dosage:          100 mg, 400 mg
OTC/RX:              RX

Indication: For the treatment of patients with chronic
myeloid leukemia (CML) in blast crisis, accelerated
phase, or in chronic phase after failure of interferon-alpha
therapy.

New Drug Application/Supplement
50-475/S-046

Approval Date:       3/26/03
Name:                Gris-PEG Tablets
Applicant:           Pedinol Pharmacal, Inc
Active Ingredients:  Griseofulvin Ultramicrosize
Dosage:              125 mg, 250 mg
OTC/RX:              RX

Indication: Supplemental new drug application provides
for the addition of "erythema-multiforme-like
drug reactions" to the ADVERSE REACTIONS section.

New Drug Application/Supplement
19-931/S-008

Name:                Klaron Lotion
Approval Date:       2/21/03
Applicant:           Dermik Laboratories, Inc
Active Ingredient:   Sulfacetamide sodium
Dosage:              10%
OTC/RX:              RX

Indication: Supplemental new drug application provides
for a new 4 oz package size.

New Drug Application/Supplement
20-965/S002

Name:                Levulan Topical Solution
Approval Date:       3/26/03
Applicant:           DUSA Pharmaceuticals, Inc
Active Ingredient:   Aminolevulinic acid
Dosage:              20%
OTC/RX;              RX

Indication: Supplemental new drug application provides
for the added statement "Excessive irritation
may be experienced if this product is applied under
occlusion" under the Warning section.

New Drug Application 21-159

Name:                Loprox Shampoo
Approval Date:       2/28/03
Applicant:           Medicis Pharmaceutical Corp.
Active Ingredient:   Ciclopirox
Dosage:              1%
OTC/RX:              RX

Indication: Loprox Shampoo, 1%, is indicated for
the treatment of seborrheic dermatitis on the scalp of
adults.

New Drug Application/Supplement NDA
50-573/S21 & S23, 50-574/S-027 & S29
& 50-625/S30 & S32

Name:                Sandimmune
Applicant:           Novartis Pharmaceuticals Corp.
Approval Date:       2/14/03
Active Ingredients:  Cyclosporine
Dosage/Formulation:  IV, Oral Solution, Soft Gelatin
Capsules, 50 mg/cc, 100 mg/cc, & 25, 50, and 100
mg, respectively
OTC/RX:              RX

Indication: Supplemental new drug application
details that the "PRECAUTIONS" subsection on
drugs that exhibit nephrotoxic synergy was renamed
"Drugs That May Potentiate Renal Dysfunction."
The following drugs were added to the list of nonsteroidal
anti-inflammatory drugs: naproxen,
sulindac, and colchicine.

New Drug Application 21-305

Name:                Sodium Iodide I-131
                     Capsules and Solution
Applicant:           DraxImage Inc
Approval Date:       1/24/03
RX/OTC:              RX

Indication: Sodium Iodide I-131 Capsules and
Solution are indicated for the treatment of hyperthyroidism
and thyroid cancer.

New Drug Application/Supplement
20-785/S20 & S21

Name:                Thalomid
Applicant:           Celgene Corporation
Approval Date:       1/17/03
Active Ingredient:   Thalidomide
Dosage Approved:     50 mg, 100 mg, and 200 mg
RX/OTC:              RX

Indication: Supplemental new drug application
provides for a change to a higher potency blend
formulation, replacement of the current marked
50 mg capsule with a new 50 mg capsule formulation,
and the introduction of a 100 mg and 200 mg