Printer Friendly

JOHNSON & JOHNSON UNIT GETS FDA APPROVAL FOR SPORANOX ANTIFUNGAL

 JOHNSON & JOHNSON UNIT GETS FDA APPROVAL FOR SPORANOX ANTIFUNGAL
 TITUSVILLE, N.J., Sept. 16 /PRNewswire/ -- Janssen Pharmaceutica Inc., a Johnson & Johnson (NYSE: JNJ) subsidiary, announced today that the U.S. Food and Drug Administration has granted marketing approval for Sporanox (itraconazole), a systemic antifungal agent for the treatment of two systemic fungal infections that can affect the lungs, skin and other parts of the body.
 Sporanox capsules are indicated for the treatment of blastomycosis and histoplasmosis.
 Histoplasmosis is one of the most common pulmonary mycoses and a frequent opportunistic infection in immunocompromised individuals living in areas in which the disease is endemic. Blastomycosis is primarily a pulmonary infection that can spread to the skin and other parts of the body. Both infections, if not treated, can be fatal.
 Clinical trials demonstrated that Sporanox was highly effective for treatment of blastomycosis and histoplasmosis. Its potential role in other fungal infections, such as aspergillosis, coccidioidomycosis and cryptococcosis, is also being studied.
 Co-administration of the antihistamine, terfenadine (Seldane), with itraconazole is contraindicated, due to increased terfenadine concentrations induced by itraconazole.
 In U.S. clinical trials prior to marketing, there have been three cases of reversible idiosyncratic hepatitis reported among more than 2,500 patients taking Sporanox. Common side effects in the U.S. clinical trials included nausea, rash and vomiting.
 Janssen anticipates the product will be available for prescription by Oct. 1.
 Itraconazole is already sold internationally by Janssen companies in over 40 countries. It is the latest in a series of topical and systemic antifungal agents discovered by Janssen scientists.
 Janssen Pharmaceutica Inc. has companies in 32 countries and was founded in 1953. It conducts research and markets products in a wide range of medical fields including allergy, anesthesiology, dermatology, oncology, psychiatry and infectious disease.
 -0- 9/16/92
 /CONTACT: F. Robert Kniffin of J&J, 908-524-3535/
 (JNJ) CO: Johnson & Johnson; Janssen Pharmaceutica Inc. ST: New Jersey IN: MTC SU:


GK -- NY051 -- 0221 09/16/92 15:00 EDT
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Sep 16, 1992
Words:327
Previous Article:CPB INC. DECLARES THIRD QUARTER CASH DIVIDEND
Next Article:U.S. EPA SETTLES PESTICIDE LABELING COMPLAINT WITH LIPHATECH
Topics:


Related Articles
JOHNSON & JOHNSON FIRST QUARTER EPS UP 13.2 PERCENT; SALES INCREASE 6.0 PERCENT
JOHNSON & JOHNSON THIRD QUARTER SALES INCREASE 17.3%; EARNINGS PER SHARE UP 17.1%
SPORANOX SETS RECORDS FOR CONSUMER RESPONSE AND PRESCRIPTIONS FOR TREATMENT OF TOENAIL FUNGUS
CYGNUS' NICOTROL(R) IS THE FIRST NICOTINE PATCH TO RECEIVE FDA APPROVAL FOR OVER-THE-COUNTER SALE
FDA Clears SPORANOX(R) Oral Solution for Oral and Esophageal Fungal Infections
New PulsePak(TM) Introduced for Treatment of Fungal Infection of Fingernails
U.S. Labeling Changes Announced for SPORANOX (itraconazole).

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters