Avodart belongs to a class of drugs called 5-alpha-reductase inhibitors, which inhibit the conversion of testosterone into dihydrotestosterone (DHT). Propecia (finasteride) also belongs to this group. However, Avodart is more effective and quicker-acting than Propecia because it inhibits both forms of 5-alpha-reductase, whereas Propecia inhibits one.

Uses

While Avodart is officially approved, and most commonly used, to treat enlargement of the prostate gland, it may also be used to treat male pattern baldness. While clinical trials for Avodart as a hair loss drug were called off in late 2002, it can still be prescribed for "off-label" purposes by physicians, and an increasing number are willing to do so.

The reason the trials were called off is not outwardly known. However, industry sources speculate that Avodart would have been seen as too similar to Propecia to have proved profitable as a hair loss treatment.

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From Journal of Drugs in Dermatology, 4/1/03

Abbreviated New Drug Application (ANDA) 76-329

Approval date: 11/6/02

Name: Amcinonide Lotion USP, .1%

Type: Generic approval for Cyclocort

Applicant: Altana, Inc.

OTC/RX status: RX

Indication of Use: Synthetic steroids primarily indicated used as anti-pruritic and anti-inflammatory agents.

ANDA 76-096

Approval date: 11/19/02

Name: Amcinonide Ointment USP, .1%

Type: Generic approval of Cyclocort

Applicant: Altana, Inc.

OTC/RX: RX

Indication of Use: Synthetic steroids primarily indicated as anti-pruritic and anti-inflammatory agents.

New Drug Application 75-945

Approval Date: 11/8/02

Name: Amnesteem

Type: Generic approval of isotretinoin

Dosage form: 10, 20, & 40 mg capsules

Applicant: Genpharm, Inc.

OTC/RX: RX

New Drug Application 21-015/S4

Approval Date: 10/22/02

Trade Name: AndroGel

Active Ingredient: Testosterone gel

Applicant: Unimed Pharmaceuticals, Inc.

OTC/RX: RX

Indication of Use: AndroGel is indicated for replacement therapy in therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

New Drug Application 21-319/S-001

Approval Date: 10/9/02

Trade Name: Avodart

Main Ingredient: Dutasteride

Applicant: GlaxoSmithKline

OTC/RX: RX

Dosage form: capsules

Indications of Use: Inhibits the conversion of testosterone to 5-alpha dihydrotestosterone (DHT), indicated for use in treatment of benign prostate hyperplasia.

ANDA 76-075

Name: Econazole Nitrate 1% cream

Approval Date: 11/26/02

Type: Generic approval

Applicant: Altana Inc.

OTC/RX: RX

ANDA 76-005

Name: Econazole Nitrate 1% cream

Approval Date: 11/26/02

Type: Generic approval

Applicant: Taro Pharmaceuticals

OTC/RX: RX

ANDA 75-990

Name: Loratadine Orally Disintegrating Tablets

Approval Date: 11/15/02

Applicant: Andrx Pharmaceuticals, Inc.

Dosage form: 10mg capsules

OTC/RX: RX

ANDA 75-183

Name: Prednisolone Sodium Phosphate Oral solution

Approval Date: 10/17/02 (tentative)

Type: Generic approval

Dosage form: Oral solution, 5mg (base/5mL)

Applicant: Hi-Tech Pharmacal Co., Inc.

OTC/RX: RX

NDA 21-454

Name: Testim 1% gel

Approval Date: 10/31/02

Active Ingredient: Testosterone

Dosage Form: 50 mg and 100 mg

Applicant: Auxilium Pharmaceuticals, Inc.

Indications for Use: Testim is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

NDA 65-113

Name: Amoxicillin Oral Suspension

Approval Date: 11/29/02

Type: Generic approval of Amoxil Oral Suspension

Dosage Form: 200 mg / 5 mL and 400 mg / 5 mL

Applicant: Ranbaxy Laboratories Ltd.

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