From FDA:
Monday February 11, 8:45 am Eastern Time
Press Release
SOURCE: Schering-Plough Corporation
Schering-Plough Announces CLARINEX(R) (desloratadine) Tablets Approved for Allergic Rhinitis and Chronic Idiopathic Urticaria
First Nonsedating Antihistamine for Both Indoor and Outdoor Allergies; CLARINEX Has Broadest Indications of Any Nonsedating Antihistamine
KENILWORTH, N.J., Feb. 11 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - news) announced today that its new antihistamine CLARINEX® (desloratadine) 5 mg Tablets has been granted the broadest indications of any nonsedating antihistamine. CLARINEX is the first and only nonsedating antihistamine approved by the U.S. Food and Drug Administration (FDA) to treat the symptoms of allergies caused by indoor and outdoor allergens in adults and children 12 years of age and older. The company said the FDA also approved CLARINEX Tablets for the treatment of chronic idiopathic urticaria (CIU), or hives of unknown cause, in the same age group. <snip>
and
Tuesday February 12, 4:00 am Eastern Time
Press Release
SOURCE: IMPAX Laboratories, Inc. Today's News On The Net - Business Wire's full file on the Internet
IMPAX ANDA Filing for Generic Version of Allegra-D Accepted By FDA
Company's Eighth Paragraph IV ANDA Filing
HAYWARD, Calif.--(BW HealthWire)--Feb. 12, 2002--IMPAX Laboratories, Inc. (Nasdaq:IPXL - news) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Allegra-D® (Fexofenadine HCl/Pseudoephedrine HCl) Extended Release 60 mg/120mg Tablets.
Aventis Pharmaceuticals Inc. markets Allegra-D® for the relief of symptoms associated with seasonal rhinitis in adults and children 12 years of age and older. U.S. sales of Allegra-D® Extended Release Tablets were over $350 million in 2001.
IMPAX's application includes a certification under Paragraph IV of the Hatch-Waxman Amendments stating the Company's belief that its product does not infringe Aventis Pharmaceuticals Inc.'s listed patents on Allegra-D® Extended Release Tablets. The FDA's acceptance of the ANDA for filing means that the agency has determined that the application is sufficiently complete so as to permit a review.
``This is our eighth filing of an ANDA under Paragraph IV with the FDA, and was our seventh filing in calendar year 2001,'' said Larry Hsu, Ph.D., President and Chief Operating Officer. ``With this filing, we continue to advance the pipeline of products that will drive our sales growth in the years to come. Looking forward, we have set a goal of filing between six and eight new ANDAs in 2002.'' <snip> |
