Formoterol: profile and news

Chiesi Farmaceutici Establishes Russian Affiliate and Forms a ...  Feb 27, 2006
...to promote Chiesi’s Modulite® platform of ozone friendly HFA respiratory products, already including Beclometasone, Budesonide and Formoterol, offering the ... - PharmaLive.com (press release),

Orion Oyj: Orion group 2005 financial statements  Feb 9, 2006
Ranbaxy in England. Budesonide and formoterol are being launched to the market as new choices in the Easyhaler franchise. Orion Pharma ... - Kauppalehti (press release),

Sepracor: arformoterol offers relief  Feb 16, 2006
Arformoterol, a single isomer of formoterol, is the first long-acting bronchodilator to be developed in an inhalation solution for use with a nebulizer. ... - Pharmaceutical Business Review

Meda AB (publ): Year-End 2005 Report  Feb 22, 2006
96% to more than SEK 240 million for all of 2005 - after launch of Novolizer budesonide 200 mcg in many European countries and of Novolizer formoterol on the ... - Genetic Engineering News,

Altana asthma drug gets additional European OK  Feb 21, 2006
...platform, which also includes a nasal spray in phase III development and a fixed combination product with long-acting beta-agonist formoterol, which is in ... - Pharmaceutical Business Review

Altana's asthma drug Alvesco granted additional approval for ...  Feb 16, 2006
Alvesco is also in phase III trials as a nasal spray, and in phase II trials as a combination treatment with long-acting beta-agonist formoterol. ... - Forbes

Alvesco (Ciclesonide) Additionally Approved for Adolescents in ...  Feb 17, 2006
...corticosteroid, the ciclesonide platform also includes a nasal spray (phase 3) and a fixed combination product with long-acting beta-agonist formoterol (phase 2 ... - DG News

Toprol XL uncertainty weighs heavy on AstraZeneca  Feb 3, 2006
...lipid-lowerer Crestor (rosuvastatin), Arimidex (anastrozole) for breast cancer and combination asthma treatment Symbicort (budesonide and formoterol). ... - Pharma Times (subscription),

Sepracor's Arformoterol NDA Filed by FDA; Drug Candidate for ...  Feb 13, 2006
...beta-agonist formulation for long-termmaintenance treatment of chronic obstructive pulmonary disease (COPD).Arformoterol, a single isomer of formoterol, is the ... - Finanzen.net,

Orion Oyj: Orion group 2005 financial statements  09 Feb 2006
Ranbaxy in England. Budesonide and formoterol are being launched to the market as new choices in the Easyhaler franchise. Orion Pharma ... - Kauppalehti (press release),

DATAMONITOR: Get SMART: Symbicort gives patients the power to ...  Jan 11, 2006
LONDON, January 11 2006- AstraZeneca is developing a new indication for its current leading asthma medication Symbicort (budesonide/formoterol), known as ... - PharmaLive.com (press release),

AstraZeneca's Symbicort gives asthma patients the power to get ...  Jan 13, 2006
AstraZeneca is focusing on Symbicort's (budesonide/formoterol) adaptability for adjustable dosing though SMART, which was formerly known as 'Single inhaler ... - Pharmaceutical Business Review

Breaking News ** Profits surge at AstraZeneca in Q4  Feb 2, 2006
...lipid-lowerer Crestor (rosuvastatin), Arimidex (anastrozole) for breast cancer and combination asthma treatment Symbicort (budesonide and formoterol). ... - Pharma Times (subscription),

New Symbicort dose a boon for AstraZeneca?  Jan 11, 2006
...allergy drugs advisory committee recommended that a warning of the concerns about long-acting beta-2 agonists also be applied to Novartis`s Foradil (formoterol ... - Monsters and Critics.com,

SkyePharma will not merge with Innovata  Jan 12, 2006
...that will improve its cash position as it continues a costly effort to bring a combination inhaled product for asthma - Flutiform (formoterol plus fluticasone ... - Pharma Times (subscription),

Verus Pharmaceuticals Appoints Tutuncu as Vice President, Medical ...  Jan 25, 2006
As Medical Director for pulmonary products, he developed and implemented clinical plans for late-stage products including budesonide, formoterol and Flutiform ... - PharmaLive.com (press release),

Inyx's Ashton Pharmaceuticals Launches Production on an Asthma Dry ...  Nov 14, 2005
...(OTC Bulletin Board: IYXI - News), announced today that it has commenced production and initial deliveries for Merck Generics, on a formoterol Clickhaler, a ... - Yahoo! News (press release)

inhalers 'can lead to attacks  Dec 4, 2005
...beta-agonist bronchodilator, such as salbutamol - increased future risk, while another type - a long-acting bronchodilator, based on formoterol - decreased it. ... - Telegraph.co.uk,

Inyx's Ashton Pharmaceuticals Launches Production on an Asthma Dry ...  Nov 14, 2005
..., announced today that it has commenced production and initial deliveries for Merck Generics, on a formoterol Clickhaler, a dry powder inhaler developed by ... - PharmaLive.com (press release),

Long-acting beta 2-adrenergic agonists may make asthma episodes ...  Nov 21, 2005
...requested manufacturers of Advair Diskus ( Fluticasone propionate & Salmeterol inhalation powder ), Foradil Aerolizer ( Formoterol fumarate inhalation powder ... - Xagena.it,

Investors 'unhappy' over drug firm's performance  Nov 27, 2005
SkyePharma has its own pipeline of pharmaceutical products that includes Flutiform and Formoterol for treating asthma, while also marketing medicines of other ... - Ireland Online,

GlaxoSmithKline winded by FDA label clampdown  Nov 24, 2005
GSK) Advair (fluticasone propionate; salmeterol xinafoate) and Serevent (salmeterol xinafoate), and on Schering-Plough's Foradil (formoterol fumarate) to ... - Pharmaceutical Business Review

Symbicort Maintenance and Reliever Therapy is Highly Effective ...  Nov 20, 2005
...and the Annual Congress of the European Respiratory Society (ERS) - demonstrate that treating patients with SYMBICORT (budesonide/ formoterol) Maintenance And ... - Medical News Today (press release),

Novartis says once-a-day asthma drug works  Nov 29, 2005
An FDA panel has ruled that Novartis’s Foradil, also a beta2-agonist and known as formoterol, should carry a similar warning. ... - Standard-Speaker,

FDA Issues Public Advisory on Three Asthma Medications  Nov 18, 2005
...xinafoate inhalation powder), Advair Diskus (fluticasone propionate and salmeterol inhalation powder) and Foradil Aerolizer (formoterol fumarate inhalation ... - MedPage Today,

FDA Has Public Health Advisory on Inhaled Long-acting ...  Nov 18, 2005
The three drugs are Advair Diskus (fluticasone propionate & salmeterol inhalation powder), Foradil Aerolizer (formoterol fumarate inhalation powder), and ... - DG News

Experts Call for Re-Focussing of COPD Management to Reduce ...  Nov 16, 2005
...are the manufacturers of Symbicort®, a combination of the inhaled corticosteroid budesonide and rapidand long-acting beta-agonist formoterol, which is ... - PharmaLive.com (press release),

Boehringer says Spiriva, formoterol cause 'superior' improvement ...  Sep 19, 2005
...induce 'superior lung function improvement' in patients who suffer from Chronic Obstructive Pulmonary Disease (COPD) when treated in combination with formoterol ... - Forbes

Long-acting beta-2 agonists linked to increased risks of asthma ...  Oct 9, 2005
The asthma medications are Salmeterol, which is sold under the brand name Serevent; Formoterol, sold as Foradil and Oxeze; as well as two combination products ... - Xagena.it,

Advisory - Safety Information About a Class of Asthma Medications ...  Oct 4, 2005
The asthma medications are salmeterol, which is sold under the brand name Serevent; formoterol, sold as Foradil and Oxeze; as well as two combination products ... - CNW Telbec (Communiqués de presse),

Some asthma drugs used improperly may increase risk of death ...  Oct 5, 2005
The beta-2 agonists are salmeterol, sold under the brand name Serevent; formoterol, sold as Foradil and Oxeze; and two combination products containing ... - Canada.com,

SkyePharma PLC (LSE: SKP; Nasdaq: SKYE) Announces Interim ...  Sep 28, 2005
Products in late-stage development Foradil(R) Certihaler(R) is our new version of Novartis' long-acting bronchodilator Foradil(R) (formoterol). ... - PR Newswire (press release),

Head-to-Head Study Shows COPD Patients Achieve Significantly ...  Sep 18, 2005
...when treated with the free combination of two bronchodilators with different modes-of-action, Spiriva(R) (tiotropium) and formoterol, compared with the free ... - PR Newswire UK (press release),

SkyePharma rights issue weighs on share price  Sep 28, 2005
Flutiform (fluticasone and formoterol) is a fixed dose combination of a corticosteroid and beta agonist that will compete with blockbuster products such as ... - in-PharmaTechnologist,

New study calls for change in the management of COPD to focus on ...  Sep 30, 2005
However, budesonide/formoterol (Symbicort®) combination inhaler is the only treatment that has been shown to reduce the frequency of exacerbations requiring ... - Medical News Today (press release),

Astrazeneca Submits New Drug Application to FDA For Symbicort® ...  Oct 1, 2005
...announced submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of SYMBICORT® (budesonide/formoterol) for the ... - Medical News Today (press release),

Indacaterol provides 24-hour efficacy with single dose in patients ...  Sep 22, 2005
...control with a single administration, in contrast to currently-available long-acting beta2-agonists (LABAs) such as salmeterol and formoterol which have to be ... - Medical News Today (press release),

Germany’s Merck sets out stall for respiratory sector  Sep 19, 2005
...said it has already secured marketing approvals for Clickhaler versions of the corticosteroid budesonide and long-acting beta agonist formoterol for the ... - in-PharmaTechnologist,

AstraZeneca Submits New Drug Application (NDA) to FDA for ...  Sep 23, 2005
...asthma. SYMBICORT is a combination of budesonide (an inhaled corticosteroid) and formoterol (a rapid and long acting beta2-agonist). ... - PR Newswire (press release),

Innovata says Merck is Euro Clickhaler partner  Sep 19, 2005
Sales of comparable budesonide products in Europe total £200m, while the European market for comparable formoterol products is estimated at more than £100m. ... - ShareCast,

Innovata reveals Merck KGaA as European Clickhaler partner  Sep 19, 2005
Respiratory has already gained marketing authorisations in a number of European markets for the Budesonide Clickhaler for asthma and Formoterol Clickhaler, for ... - Forbes

Novartis says once-a-day asthma drug works  Sep 19, 2005
...deaths. An FDA panel has ruled that Novartis's Foradil, also a beta2-agonist and known as formoterol, should carry a similar warning. ... - ABC News

Study backs Novartis on once-a-day asthma drug  Sep 19, 2005
A Food and Drug Administration panel has ruled that Novartis's Foradil, also a beta2-agonist and known as formoterol, should carry a similar warning. ... - Newark Star Ledger,

HEALTH BRIEFS  Sep 12, 2005
Consumer Reports on Health says researchers subjected formoterol, an inhaled asthma medicine, to the equivalent of a hot car or mailbox. ... - Kansas.com,

(PRN) - Thermo Electron to Present at the 2005 UBS Global Life ...  Sep 23, 2005
...(PRN) - AstraZeneca Submits New Drug Application (NDA) to FDA for SYMBICORT(R) (budesonide/formoterol) for the Maintenance Treatment of Asthma ... [+. ... - Bolsamania.com,

AstraZeneca files NDA for Symbicort  Sep 23, 2005
...treatment of asthma. Symbicort is a combination of two drugs -- budesonide and formoterol -- delivered via an inhaler. AstraZeneca said ... - United Press International

Merck KGaA Establishes International Respiratory Medicines ...  Sep 19, 2005
Merck Respiratory already has gained marketing authorizations for its Budesonide Clickhaler(R) for the treatment of asthma and Formoterol Clickhaler(R), for ... - PharmaLive.com (press release),

SkyePharma Announces FORADIL(R) CERTIHALER(TM) Launched in Germany  Sep 7, 2005
Nasdaq: SKYE; LSE: SKP) announces today that its partner Novartis Pharma AG (Novartis) has launched FORADIL(R) CERTIHALER(TM) (formoterol fumarate inhalation ... - PR Newswire (press release),

ASTHMA DRUGS REVIEWED  Jul 26, 2005
THE US Food and Drug Administration will keep three leading asthma drugs on the market and add boxed warnings to Foradil (formoterol, marketed in Australia as ... - AustralianDoctor.com (subscription)

Serevent, Advair, Foradil Withdrawals To Be Considered By Advisory ...  Jul 12, 2005
...data concerning rare severe asthma exacerbations with Serevent (salmeterol), Advair (fluticasone propionate/salmeterol) and Foradil (formoterol) (“The Pink ... - FDA Advisory Committee

FDA Considers Withdrawal of Asthma Drugs  Jul 13, 2005
The committee is considering three products but only two long-acting beta- agonist drugs are at issue: salmeterol xinafoate and formoterol fumarate, both of ... - Forbes

Green light for asthma drugs  Jul 14, 2005
...focused its attentions on the three products, but only two long-acting, beta-agonist drugs were at issue: salmeterol xinafoate and formoterol fumarate, both of ... - Health24.com

MAP Pharma extends respiratory alliance with Elan  Jul 28, 2005
...major products, GlaxoSmithKline’s Seretide (salmeterol and fluticasone propionate) and AstraZeneca’s Symbicort (budesonide and formoterol), dominating the ... - in-PharmaTechnologist

FDA Considers Withdrawal of Asthma Drugs  Jul 13, 2005
The committee is considering three products but only two long-acting beta- agonist drugs are at issue: Salmeterol xinafoate and Formoterol fumarate, both of ... - HealthCentral.com

Experts to Consider Withdrawal of Asthma Drugs  Jul 13, 2005
Foradil does not contain salmeterol; its active ingredient is formoterol. The drugs are inhaled to keep the airways open, preventing asthma attacks. ... - New York Times

Health Highlights: July 13, 2005  Jul 13, 2005
Times reported. Advair and Serevent both contain the drug salmeterol while the active ingredient in Foradil is formoterol. Advair ... - Atlanta Journal Constitution (subscription)

FDA backs sales of asthma drugs  Jul 14, 2005
The panel also backed continued sales of Foradil, a closely related drug known generically as formoterol, but recommended stronger warnings about potential ... - Science Daily (press release)

FDA Advisers Endorse Stronger Warnings for Embattled Asthma Drugs  Jul 15, 2005
ROCKVILLE, Md., July 15-FDA advisers have recommended that the asthma drugs Advair (fluticasone propionate/salmeterol), Foradil (formoterol), and Serevent ... - MedPage Today

NJ business briefs  Jul 13, 2005
People taking Foradil, or formoterol, in a study at higher than the current recommended dose showed some worsening of their asthma, the FDA said. ... - NorthJersey.com

FDA Panel Reviewing 3 Asthma Drugs  Jul 13, 2005
Times reported. Advair and Serevent both contain the drug Salmeterol while the active ingredient in Foradil is Formoterol. Advair ... - HealthCentral.com

Short-Acting ß₂-agonists: Aerosol bronchodilators of the short-acting adrenergic stimulant type may be used for relief of breakthrough symptoms while using formoterol. However, increasing use of such preparations to control symptoms indicates deterioration of asthma control and the need to reassess the patientís therapy.

Concomitant administration of other sympathomimetic agents may potentiate the undesirable effects of FORADIL.

Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: FORADIL should be administered with extreme caution in patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants because the action of formoterol on the cardiovascular system may be potentiated by these agents.

Corticosteroids, Methylxanthines and Diuretics: Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalemic effect of ß₂-agonists. Hypokalemia may increase susceptibility to cardiac arrhythmias in patients treated with digitalis.

ß-adrenergic Blockers: ß-adrenergic blockers may weaken or antagonise the effect of FORADIL. Therefore FORADIL should not be given together with ß-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.

Other Drugs:Drugs such as quinidine, disopyramide, procainamide, phenothiazines, antihistamines, and tricyclic antidepressants may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia.

INFORMATION TO BE PROVIDED TO THE PATIENT OR GUARDIAN

See illustrated Information For The Patient or Guardian section. It is important that patients understand how to use FORADIL® (formoterol fumarate) capsules with the supplied Aerolizer^TM inhalation device and how it should be used in relation to other asthma or COPD medications they are taking. Patients/Guardians should be given the following information:

i. The recommended dosage (one or two capsules twice daily, morning and evening) should not be exceeded.

ii. FORADIL is not meant to relieve acute asthma or COPD symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with a short-acting, inhaled ß₂ -agonist such as salbutamol (the physician should provide the patient with such medication and instruct the patient in how it should be used).

iii. The physician should be notified immediately if any of the following situations occur, which may be a sign of seriously worsening asthma:

ï Decreased effectiveness of short-acting, inhaled ß₂- agonists;

ï Need for more inhalations than usual of short-acting, inhaled ß₂ -agonists.

iv. FORADIL should not be used as a substitute for oral or inhaled corticosteroids. The dosage of these medications should not be changed and they should not be stopped without consulting the physician, even if the patient feels better after initiating treatment with FORADIL.

v. Patients should be cautioned regarding potential adverse cardiovascular effects, such as palpitations or chest pain.

vi. In patients receiving FORADIL, other inhaled medications should be used only as directed by the physician.

vii. Guardians of children who have been prescribed FORADIL should be alerted to the general concern regarding asthma therapy compliance, especially neglect of anti-inflammatory therapy and overuse of short-acting ß₂-agonists.