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Barr Pharmaceuticals, Inc. (NYSE: BRL) announced that its subsidiary Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Aventis Pharmaceuticals’ Allegra (Fexofenadine Hydrochloride) Capsules, 60 mg. The Company is the first applicant to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV patent challenge on the patents related to the Allegra capsule product, and is entitled to 180 days of marketing exclusivity on the product.
Allegra (Fexofenadine Hydrochloride) is indicated for the relief of symptoms associated with seasonal allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. Allegra (Fexofenadine Hydrochloride) Capsules, 60 mg, which had annual sales of approximately $14,000 based on IMS data for the twelve months ended May 2005, is no longer marketed by Aventis.
Barr filed an ANDA for Fexofenadine Hydrochloride Capsules, 60 mg, in May 2001. Following receipt of notice of acceptance from FDA, Barr notified Aventis of its ANDA filing. Aventis filed suit in the United States District Court for the District of New Jersey seeking to prevent approval of Barr’s ANDA until after the expiration of various patents, the last of which expires in 2017.
Reports of fexofenadine overdose are infrequent, and because of this, the effects are not well established. No deaths occurred in testing on mice, at 5000 mg/kg, which is 110 times the maximum recommended dose for an adult human. Further research shows no deaths in rats at the same concentration, which equates four hundred times the recommended dose in an adult human. Research on humans ranges from a single 800 mg dose, to a twice-daily 690 mg dose for a month, with no clinically significant adverse effects, when compared to a placebo.
Antihistamines are the antidote to exposure to histamine. As their name
implies, antihistamines are able to block the effects of histamine in your
body. [You should think of antihistamines as being the bouncer at
a club].
When histamine molecules get onto the surface of the cell, they cause
inflammation and irritation.
Antihistamines displace the histamine molecules from the cell and form
a protective shield around the cells so that histamine can not interact
with the cell to cause an allergic reaction.
1.
Benefits: Allergic reactions stopped almost immediately
Side effects: Very dry skin and hyperactivity
Comments: Took medication when symptoms arose, stopped when subsided
2.
Benefits: It helps with sneezing but my nose runs like a faucet. It relieves my itching eyes, I don’t cough as much.
Side effects: none - I don’t recall anything
Comments: I’ve struggled with allergies for 20 yrs. Very few drugs help me however this drug does at least slow down the reaction to allergins. I’m going to try Zyrtec now that it is OTC. I’ve tried benedryl and claritin which don’t help.
3.
Benefits: I had terrible itching, watery eyes, and sneezing from seasonal allergies. This medication did not completely elimiate my symptoms, but is reduced them to a tolerable level without making me too tired or doped up to function at work.
Side effects: I think I did experience some drowsiness from the medication, but nothing that was overly so such that I could not function at work.
Comments: The doseage was one pill/day
The older antihistaminic agent terfenadine was found to metabolize into the related carboxylic acid, fexofenadine. Fexofenadine was found to retain all of the biological activity of its parent while giving fewer adverse reactions in patients, so terfenadine was replaced in the market by its metabolite.[5] Fexofenadine was originally synthesized in 1993 by Massachusetts-based biotechnology company Sepracor, which then sold the development rights to Hoechst Marion Roussel (now part of Sanofi-Aventis), and was later approved by the Food and Drug Administration (FDA) in 1996. AMRI holds the patents to the intermediates and production of fexofenadine HCl along with Roussel. Since that time, it has achieved blockbuster drug status with global sales of $1.87B USD in 2004 (with $1.49B USD coming from the United States). AMRI received royalty payments from Aventis that enabled the growth of AMRI.
Take this Allegra medication by mouth on an empty stomach 1 hour before or two hours after meals as directed, usually twice daily. Taking this Allegra medicine with a high fat meal can decrease its effectiveness. Do not take antacids containing aluminum and magnesium within 2 hours of taking this Allegra medication. Swallow the Allegra medicine whole. Do not crush or chew the Allegra tablet, and do not take more than prescribed. Do not take this Allegra product within 14 days after stopping an MAO Inhibitor.
Allegra is effectively used to treat allergic symptoms like itchy red eyes, stuffy nose and throat irritation. It contains antihistamine and decongestant, and can be consumed orally on an empty stomach 1 to 2 hours before lunch, twice daily.
Allegra is recommended that you avoid high fat meal while consuming these tablets as they could slower the effectiveness of this medicine. It is necessary that take the dosage as prescribed by your doctor and should be swallowed in entirety. Please do not crush or chew the tablets or take more than prescribed. Avoid taking antacids containing aluminum and magnesium within 2 hours of taking this medication or within 14 days after stopping an MAO Inhibitor.
Please inform your doctor if you have a medical history of allergies, kidney/urinary problems, enlarged prostate, glaucoma (narrow angle), severe high blood pressure, heart disease, diabetes, thyroid problems (hyperthyroid). The consumption of alcohol is also not permissible when taking this drug as it could aggravate its side effects.
Please avoid the usage of this drug during pregnancy or breast feeding. If it is very necessary to consume the same please consult your doctor or medical practitioner before using the same. Also inform your doctor if you are planning to take or are already taking any prescription or nonprescription drug.
On event of an overdose please contact your local poison control center or hospital immediately. A few of the symptoms of overdose may include irregular or unusually slow or fast heartbeat, unusual nervousness or excitement, rapid breathing, confusion, hallucinations, and seizures.
Some moderate side effects like nausea, stomach upset, trouble sleeping, headache, or cold symptoms may occur. If these persist or worsen, notify your doctor immediately. If you find any of the symptoms not listed above please get in touch with your doctor immediately.
Fexofenadine is an oral, “second generation” antihistamine that is used to treat the signs and symptoms of allergy that are due to histamine. It is similar to the other second generation antihistamines loratadine (Claritin), cetirizine (Zyrtec) and azelastine (Astelin). Histamine is a chemical that is responsible for many of the signs and symptoms of allergic reactions, for example, swelling of the lining of the nose, sneezing, and itchy eyes. Histamine is released from histamine-storing cells (mast cells) and then attaches to other cells that have receptors for histamine. The attachment of the histamine to the receptors causes the cell to be “activated,” releasing other chemicals that produce the effects that we associate with allergy, e.g., sneezing. Fexofenadine blocks one type of receptor for histamine (the H1 receptor) and thus prevents activation of H1 receptor-containing cells by histamine. Unlike the first generation antihistamines, fexofenadine and other second-generation antihistamines do not readily enter the brain from the blood, and, therefore, they cause less drowsiness. Fexofenadine was approved by the FDA in July, 1995.
The onset of action for Allegra was observed at one hour in a controlled clinical trial. Additional studies demonstrated that allergy sufferers continued feeling relief throughout the 12-hour dosing period. Also, two-week trials showed that Allegra provided significant symptom relief throughout the full course of therapy.