Allegra-D: profile and news

UPDATE 2-Barr earnings beat targets, shares rise  Feb 7, 2006
Wall Street is waiting to see if Barr can capitalize on patent challenges to two popular drugs, Allegra D for allergies and Adderall XR for hyperactivity ... - Reuters

Barr's Generics Pipeline Includes Near-Term Catalysts  Feb 7, 2006
He cited as catalysts generic versions of the allergy medication Allegra-D from Sanofi-Aventis (nyse: SNY - news - people ), the hyperactivity treatment ... - Forbes

Sanofi-Aventis sues Teva for Allegra D patent infringement  Jan 22, 2006
Sanofi-Aventis accuses Teva of infringing its patent to Allegra D, an allergy treatment, which has $2 billion in annual sales, and is one of Sanofi-Aventis ... - Globes,

UPDATE 2-Barr earnings beat targets, shares rise  Feb 7, 2006
Wall Street is waiting to see if Barr can capitalize on patent challenges to two popular drugs, Allegra D for allergies and Adderall XR for hyperactivity ... - Reuters

Barr's Generics Pipeline Includes Near-Term Catalysts  Feb 7, 2006
He cited as catalysts generic versions of the allergy medication Allegra-D from Sanofi-Aventis (nyse: SNY - news - people ), the hyperactivity treatment ... - Forbes

Histamine blockers fight allergy symptoms  Dec 4, 2005
Because antihistamines normally do not decrease nasal congestion, they are frequently combined with a decongestant (D) such as Allegra-D, Zyrtec-D, and Claritin ... - Daytona Beach News-Journal,

LePharmacy.com Distributes Award Winning ALS Documentary ...  Nov 28, 2005
...free DVD’s of an award winning documentary to their customers living with ALS who purchase low cost Rilutek, Gabapentin, Baclofen, Allegra D, Quinine Sulfate ... - PR Web (press release),

Boca drug firm gets FDA approval for pill  Nov 30, 2005
Its only other US drug, Allegra D 24-hour, was co-developed with Paris-based Sanofi-Aventis. It's a prescription antihistamine for allergy relief. ... - Palm Beach Post,

Ignoring rain, fans in Tarrytown jockey to see De Niro, Damon  Nov 10, 2005
...camera phones. "He's not a piece of meat, for crying out loud!" yelled Allegra D'Alo, a first-year student at Marymount College. D ... - The Journal News.com,

Hires set the stage for Albany Molecular's new focus on legal ...  Oct 3, 2005
...not. "Everything we've been looking at for the past few years was from the perspective of life after Allegra," D'Ambra said. "Allegra ... - MSNBC

Sanofi-aventis Group Enters Agreement With Prasco Laboratories to ...  Sep 12, 2005
...and flexibility in treating their different seasonal allergy needs: Allegra 30 mg and 60 mg twice-daily; Allegra 180 mg once-daily; Allegra-D 12-Hour ... - PR Newswire (press release),

AMRI Files Motion for Preliminary Injunction Against Manufacturers ...  Sep 21, 2005
District of New Jersey against several generic pharmaceutical manufacturers based on patents relating to Sanofi-Aventis' ALLEGRA(R) and ALLEGRA-D(R) products. ... - Genetic Engineering News,

Barr, Teva to market generic Allegra  Sep 7, 2005
Allegra, Cox said. Barr also has approval to sell a generic form of Allegra-D, the extended-release form of the drug. Cox said no ... - Boston Globe,

NC drug maker moving to Boca to join burgeoning biotech sector  Aug 25, 2005
...versions. One example is Allegra-D 24 Hour, an 24-hour allergy medication Osmotica co-developed with Sanofi-Aventis. Osmotica's ... - Fort Lauderdale Sun Sentinel,

Sanofi-aventis Announces Strong Growth In 2005  Aug 30, 2005
Recent events July 25, 2005 Sanofi pasteur begins shipping Adacel(TM) vaccine in the United States July 27, 2005 Launch of Allegra®-D 24 hours in the United ... - Yahoo! News (press release)

Fall allergies  Aug 19, 2005
Over-the-counter and prescription medications such as Benadryl, Claritin-D, Allegra-D and antihistamines have not worked for her. ... - Blue Springs Examiner,

Allegra-D 24 Hour (fexofenadine HCl 180 mg/pseudoephedrine HCl 240 ...  Jul 27, 2005
BRIDGEWATER, NJ, July 27, 2005 – Sanofi-aventis announced today that Allegra-D ® 24 Hour (fexofenadine HCl 180 mg/pseudophedrine HCl 240 mg) Extended ... - PharmaLive.com (press release)

UPDATE 1-US FDA clears Barr's generic version of Allegra  Jul 14, 2005
Barr also has FDA approval for the 12-hour Allegra-D tablet, which is also locked up in a legal fight. "The market is really in ... - Reuters

Barr gets FDA OK for version of Allegra  Jul 14, 2005
...stopped marketing the 60 milligram capsule version of the drug in the past year to focus on tablets and its extended-release version, Allegra-D. Since the ... - BusinessWeek

Strong net sales growth in the first half of 2005: 11.0% on a ...  Jul 19, 2005
In the United States, Allegra(R) recorded a 3.2% rise in net sales to 343 million euros. Allegra-D 24 hours is due for launch in the United States shortly. ... - Canada NewsWire (press release) <**results**>

FDA approves Barr's generic antidiuretic  Jul 5, 2005
...a lawsuit of its own against the FDA in February 2005 over its right to sell a generic version of Sanofi-Aventis SA's Allegra-D prescriptionallergy treatment. ... - New York Business,

Drug Interaction with Erythromycin and Ketoconazole

Fexofenadine has been shown to exhibit minimal (ca. 5%) metabolism. However, coñ administration of fexofenadine hydrochloride with either ketoconazole or erythromycin led to increased plasma concentrations of fexofenadine. Fexofenadine had no effect on the pharmacokinetics of either erythromycin or ketoconazole. In 2 separate studies, fexofenadine hydrochloride 120 mg twice daily (240 mg total daily dose) was co-administered with either erythromycin 500 mg every 8 hours or ketoconazole 400 mg once daily under steady-state conditions to healthy volunteers (n=24, each study). No differences in adverse events or QTc interval were observed when subjects were administered fexofenadine hydrochloride alone or in combination with either erythromycin or ketoconazole. The findings of these studies are summarized in the following table:

Effects on steady-state fexofenadine pharmacokinetics after 7 days of
co-administration with fexofenadine hydrochloride 120 mg every 12 hours
(two times the recommended twice daily dose) in healthy volunteers (n=24)

The changes in plasma levels were within the range of plasma levels achieved in adequate and well-controlled clinical trials.

The mechanism of these interactions has been evaluated in in vitro, in situ, and in vivo animal models. These studies indicate that ketoconazole or erythromycin co-administration enhances fexofenadine gastrointestinal absorption. This observed increase in the bioavailability of fexofenadine may be due to transport-related effects, such as p-glycoprotein. in vivo animal studies also suggest that in addition to enhancing absorption, ketoconazole decreases fexofenadine gastrointestinal secretion, while erythromycin may also decrease biliary excretion.

Drug Interactions with Antacids

Administration of 120 mg of fexofenadine hydrochloride (2 x 60 mg capsule) within 15 minutes of an aluminum and magnesium containing antacid (Maalox®) decreased fexofenadine AUC by 41% and c_max by 43%. ALLEGRA should not be taken closely in time with aluminum and magnesium containing antacids.

Interactions with Fruit Juices

Fruit juices such as grapefruit, orange and apple may reduce the bioavailability and exposure of fexofenadine. This is based on the results from 3 clinical studies using histamine induced skin wheals and flares coupled with population pharmacokinetic analysis. The size of wheal and flare were significantly larger when fexofenadine hydrochloride was administered with either grapefruit or orange juices compared to water. Based on the literature reports, the same effects may be extrapolated to other fruit juices such as apple juice. The clinical significance of these observations is unknown. In addition, based on the population pharmacokinetics analysis of the combined data from grapefruit and orange juices studies with the data from a bioequivalence study, the bioavailability of fexofenadine was reduced by 36%. Therefore, to maximize the effects of fexofenadine, it is recommended that ALLEGRA should be taken with water.