среда, 12 марта 2008 г.

Allergan comments on the united states department of justice subpoena for the production of documents relating to promotional practices of botox for therapeutic uses

AGN) today announced that it received a subpoena from the United States Department of Justice, United States Attorney's Office for the Northern District of Georgia requesting the production of documents regarding promotional practices involving BOTOX(R) (botulinum toxin type A) for therapeutic indications.The subpoena broadly requests documents regarding promotional, educational and other activities relating to BOTOX(R).Current understanding is that the inquiry involves questions regarding alleged off label promotion relating to the use of BOTOX(R) for the treatment of headache.Allergan is currently in phase III clinical studies investigating the use of BOTOX(R) for the treatment of headache, this is not an FDA-approved use.Although healthcare professionals, exercising their medical judgment, may generally prescribe or dispense a drug for indications not approved by the FDA (i.Off label), it is Allergan's policy to promote its products only in a manner consistent with the FDA-approved product labeling.In all circumstances, it is Allergan's policy to fullyply with all applicable laws, rules and regulations.Healthcare Lawpliance Program is intended to ensure continuedpliance with all applicable laws, regulations and industry guidance governing the sale and marketing of pharmaceutical and medical device products, as well as laws and regulations governing the reporting of prices for Government-reimbursed products.Since its first approval in 1989, BOTOX(R) is indicated and used in the United States to treat a variety of often serious medical conditions, including cervical dystonia, blepharospasm, strabismus and hyperhidrosis, and is approved for 20 different indications by regulatory authorities across 70 countries worldwide.Allergan will provide updates as it responds to the subpoena, and will fully cooperate with the U.Department of Justice to satisfactorily address any and all of their questions regarding this matter.Important BOTOX(R) (Botulinum Toxin Type A) Information BOTOX(R) is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.BOTOX(R) is also indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.The efficacy of BOTOX(R) treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established.Is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.And BOTOX(R) is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.Important BOTOX(R) (Botulinum Toxin Type A) Safety Information BOTOX(R) treatment should not be injected in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation.Serious heart problems and serious allergic reactions have been reported rarely.You think you're having an allergic reaction or other unusual symptoms, such as difficulty swallowing, speaking or breathing, call your doctor immediately.With peripheral motor neuropathic diseases (e.Amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorders (e.Myasthenia gravis or Lambert-Eaton syndrome) should only receive BOTOX(R) with caution.With neuromuscular disorders may be at increased risk of clinically significant systemic side effects with BOTOX(R).Full prescribing information, please visit www.Www.BOTOX(R) for Blepharospasm in Patients greater than or equal to 12 Years of Age: Reduced blinking from BOTOX(R) injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal perforation.Most frequently reported treatment-related adverse reactions in these patients are ptosis (20.Punctate keratitis (6.Eye dryness (6.BOTOX(R) for Strabismus in Patients greater than or equal to 12 Years of Age: Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double vision or past pointing.Reported adverse effects are ptosis (16%) and vertical deviation (17%).BOTOX(R) for Cervical Dystonia in Adults: There have been rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube.Most frequently reported adverse reactions in patients with cervical dystonia are dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).BOTOX(R) for Severe Primary Axillary Hyperhidrosis Inadequately Managed with Topical Agents: The most frequently reported adverse events (3 - 10%) are injection site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.Forward-Looking Statements This press release contains "forward-looking statements," including statements regarding a federal subpoena and statements regarding the safety, effectiveness and adverse events associated with BOTOX(R).These statements are based on current expectations of future events.Assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections.And uncertainties include, among other things, general industry, economic, biologic and pharmaceutical market conditions; technological advances and patents attained bypetitors; challenges inherent in the research and development and regulatory processes; inconsistency of treatment results among patients; potential difficulties in manufacturing; and governmental laws and regulations affecting domestic and foreign operations.Information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchangemission, including the discussion under the heading "Risk Factors" in Allergan's 2007 Form 10-K.Of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.You can contact the Allergan Investor Relations Department by calling 1-714-246-4636.About Allergan, Inc.In 1950, Allergan, Inc.Headquarters in Irvine, California, is a multi-specialty health carepany that discovers, develops andmercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully.Employs more than 7,500 people worldwide and operates state-of-the-art R padding:0px;" method="get" action="" onsubmit="return false"> Services Recent Searches Recently Approved Most Popular Internet Searches Latest FDA Drug Alerts March 4, 2008 Audience: Consumers, healthcare professionals FDA. Latest Drug Information Updates Simcor (Niaspan/simvastatin) is a fixed-dosebination lipid therapy used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol and triglycerides, and to increase HDL "good" cholesterol.Factor (Rbinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood.Is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.Accretropin (somatropin (rDNA origin)) is rbinant human growth hormone indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone, or treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.Moxatag is a once-daily extended-release formulation of the penicillin antibiotic amoxicillin indicated for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to _Streptococcus pyogenes_ monly referred to as strep throat).Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which inbination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.HCT (aliskiren and hydrochlorothiazide) is a single-tabletbination therapy for the treatment of high blood pressure.Flo-Pred (prednisolone acetate) is a cherry flavored oral liquid corticosteroid formulation which does not require refrigeration and does not require shaking prior to use.Is an anti-inflammatory agent for the treatment of asthma, certain allergic and dermatologic conditions, as well as a variety of other indications.Alvesco (ciclesonide) is an inhaled corticosteroid indicated for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older.Is a rbinant form of human thrombin is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.Be used in conjunction with an absorbable gelatin sponge, USP.(nebivolol) is a once daily beta blocker approved for the treatment of hypertension.Kuvan is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase (PAH) to metabolize phenylalanine (Phe).Indicated for the treatment of phenylketonuria, an inherited metabolic disease caused by a deficiency of the enzyme phenylalanine hydroxylase (PAH).Triesence is a synthetic corticosteroid indicated for visualization during vitrectomy and treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.Mircera is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic renal failure.Is an alpha adrenergic receptor agonist and beta adrenergic receptor inhibitorbination ophthalmic solution for the reduction of elevated intraocular pressure (IOP) in patients with glaa or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.Relaxane is abination of botanical extracts formulated to relieve the symptoms of everyday stress such as irritability, restlessness, stress-related minor muscle pain and stress-related gastrointestinal difort.- - - - - - - - - - - The drugs drug database is powered by MicromedexTM, Facts &parisonsTM and MultumTM.Data last updated 8 January 2008.
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