GlaxoSmithKline – Products

About

– Every second: Distributes more than 35 doses of vaccine.
– Every minute: More than 1,100 prescriptions are written for GSK products.
– Every hour: Spends more than $562,000 to find new medicines.
– Every day: More than 200 million people use a GSK brand toothbrush or toothpaste.
– Every year: Produces 9 billion Tums tablets, 6 billion Panadol tablets and 600 million tubes of toothpaste.
– GlaxoSmithKline is a corporate member of the Council on Foreign Relations.

Products

2009
European Commission‘s approvals: Synflorix, paediatric pneumococcal vaccine for meningitis and bacteraemic pneumonia, and middle ear infections; Alli (orlistat 60mg), first non-prescription product for weight loss.
World Health Organization global prequalification to Rotarix, vaccine against rotavirus, necessary for UN agencies and the GAVI Alliance to purchase rotavirus vaccines on behalf of developing countries. The WHO’s Strategic Advisory Group of Experts also recommends that rotavirus vaccination be included in all national immunisation programmes. Opens the door to making rotavirus vaccines available to children worldwide, accelerates access to the vaccine in Asia and Africa and expands on the WHO decision taken in 2007 to prequalify the vaccine for Europe and the Americas.
WHO prequalification to Cervarix, cervical cancer vaccine, necessary for UN agencies and the GAVI Alliance to purchase the vaccine in partnership with developing countries and help speed access globally.
– The 10-valent pneumococcal conjugate vaccine Synflorix approved by Brazilian regulatory authorities.
– Collaboration with Amgen to share commercialization of monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand and Mexico. Amgen to commercialize the drug for PMO and oncology in the U.S. and Canada and for all oncology indications in Europe and specified markets.
– Actiprotect, disposable respirator mask specifically designed with a coating with antiviral effectiveness, approved in Europe and certain international markets, and for occupational use in the USA.
– Withdraw the Marketing Authorisation Application in the EU for mepolizumab for the treatment of hypereosinophilic syndrome.
– Exclusive agreement with President Trading Co. Ltd, a wholly-owned trading arm of Uni-President China Holdings Ltd, one of the leading food and beverage companies in China, to launch GSK’s Lucozade drinks franchise across China.
FDA approvals: Votrient (pazopanib), to treat patients with advanced renal cell carcinoma, a form of kidney cancer; Cervarix (Human papillomavirus bivalent types 16 and 18 vaccine, recombinant), for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus types 16 and 18 for use in girls and young women (aged 10-25).
– Cervarix becomes the first cervical cancer vaccine to be approved by the Japanese Ministry of Health, Labour and Welfare. Cervarix, formulated with innovative AS04 adjuvant system, licensed for the prevention of pre-cancerous lesions (cervical intraepithelial neoplasia – CIN 2 and 3) and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by human papillomavirus types 16 and 18, in girls and women aged 10 and above. This landmark approval is the 99th licence obtained to date around the world. These include the 27 member states of the European Union, Australia, Brazil, South Korea, Mexico and Taiwan.
– GSK and Genmab A/S announce accelerated approval of Arzerra (ofatumumab) from the FDA for use in patients with chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab.
World Health Organization prequalification for global use of Synflorix, GlaxoSmithKline Biologicals’ pneumococcal conjugate vaccine. The WHO prequalification allows UN agencies to purchase vaccines on behalf of developing countries and will accelerate global access to Synflorix.
– Licensing agreement with Gilead Sciences Inc. to commercialise Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B infection in adults in five countries in Asia. Gilead‘s exclusive rights for commercialisation in Hong Kong, Singapore, South Korea and Taiwan. GSK’s exclusive commercialisation rights and registration responsibilities in China. Each company will pay royalties to the other on sales in their respective Asian territories. Companies working to expand this agreement to include Japan and other countries.

2008
European Commission‘s approvals: Once-daily Avamys (fluticasone furoate) nasal spray for the treatment of the symptoms of allergic rhinitis in adults, adolescents and children; Volibris (ambrisentan) for the treatment of Functional Class II and III Pulmonary Arterial Hypertension; Avodart (dutasteride) with tamsulosin for the treatment of benign prostatic hyperplasia.
FDA‘s approvals: Promacta (eltrombopag), the first oral medication to increase platelet production for people with serious blood disorder; Requip XL (ropinirole extended-release tablets) for the treatment of the signs and symptoms of idiopathic Parkinson’s disease; Rotarix (Rotavirus Vaccine, live, oral) for the prevention of rotavirus gastroenteritis in infants (by 4 months of age); Advair 250/50 for the reduction of exacerbations in patients with chronic obstructive pulmonary disease; Tyverb (lapatinib), the first oral targeted therapy for ErbB2-positive breast cancer.
– GSK and Synta Pharmaceuticals Corp. announce orphan drug designation by the FDA to Elesclomol (STA-4783) for the treatment of patients with metastatic melanoma.
– GSK and POZEN Inc. announce FDA‘s approval of Treximet (sumatriptan and naproxen sodium) tablets for acute treatment of migraine.
– Worldwide exclusive agreement with Amira Pharmaceuticals to develop, manufacture and commercialise FLAP (5-Lipoxygenase Activating Protein­) inhibitors for the treatment of respiratory and cardiovascular disease.
– Cervical cancer vaccine, Cervarix, confirmed by the Netherlands Vaccine Institute as the cervical cancer vaccine for the Dutch National Immunisation Programme to vaccinate all 12 year old girls.
– Agreed to sell Eltroxin, Lanoxin, Imuran and Zyloric to a subsidiary of the South African based pharmaceuticals group, Aspen Global Inc. for £170 million.
– Agreement with Laclede to purchase the leading Dry Mouth brand Biotene for $170 million.
– Cervical cancer vaccine, Cervarix, confirmed as the UK Department of Health‘s vaccine of choice for its national human papillomavirus immunisation programme to vaccinate girls aged 12 to 13 each year.
– Exclusive worldwide collaboration (excluding Japan) with Actelion Ltd. to realise the full potential of Almorexant in sleep disorders and beyond.
– Donation of 600 million treatments for lymphatic filariasis.

2007
European Commission‘s approvals: new scored-tablet formulations of HIV fixed-dose combination medicines Combivir, Epivir (lamivudine/3TC) and Ziagen (abacavir) for use in children weighing more than 14kg; Wellbutrin XR, first once-daily noradrenaline dopamine reuptake inhibitor for the treatment of Major Depressive Disorder; cervical cancer vaccine, Cervarix; new indication for its once-daily anticoagulant ARIXTRA 2.5 mg (fondaparinux sodium) for the treatment of specific acute coronary syndromes; Atriance (nelarabine), for the treatment of difficult-to-treat leukaemias and lymphomas; novel topical antibacterial ALTARGO (retapamulin ointment, 1%) for the treatment of impetigo and infected small lacerations, abrasions or sutured wounds.
FDA‘s approvals: the once-daily anticoagulant ARIXTRA (fondaparinux sodium) Injection; the weight-loss product orlistat 60 mg capsules; the New Drug Application for Requip (ropinirole) XL Extended-Release Tablets for the treatment of the signs and symptoms of idiopathic Parkinson’s disease; oral Hycamtin (topotecan) capsules for the treatment of relapsed small cell lung cancer; once-daily Veramyst (fluticasone furoate) Nasal Spray for treatment of seasonal and year-round allergy symptoms in adults and children as young as 2 years; antibacterial Altabax for the topical treatment of impetigo; Twinrix (Hepatitis A Vaccine (Inactivated) and Hepatitis B (Recombinant) Vaccine), for an accelerated dosing schedule that consists of 3 doses given within 3 weeks followed by a booster dose at 12 months; Coreg CR (carvedilol phosphate) extended-release capsules, a once-a-day beta-blocker to treat three cardiovascular conditions; Tykerb (lapatinib), in combination with Xeloda (capecitabine), for the treatment of advanced or metastatic breast cancer.
– The Ministry of Health, Labour and Welfare in Japan approves Seretide/Advair Diskus (salmeterol and fluticasone proprionate combination) and Arixtra (fondaparinux sodium).
– Swiss approval of Tyverb, a new oral treatment for advanced breast cancer.
Cervarix approved in Australia for use in females aged 10 to 45 years old. Approved in more than 80 countries including the European Union, Mexico, Singapore and the Philippines.
– GSK and Adolor Corporation provide an update on the alvimopan (Entereg/Entrareg) development programme.
– GSK acquires from Roche Group exclusive rights to the weight-loss medicine, Orlistat, for over-the-counter use in markets outside the U.S., excluding Japan.
– GSK, via its Centre Of Excellence for External Drug Discovery, exercises options to further develop and commercialise Exelixis Inc.‘s anti-cancer C-Met inhibitior XL880.
– Rotarix, first rotavirus vaccine to obtain the prequalification status by WHO.
Prometheus Laboratories Inc. acquires exclusive rights in the U.S. to GSK’s Lotronex (alosetron hydrochloride) Tablets, only prescription drug approved by the FDA for use in adult female patients with severe diarrhea-predominant irritable bowel syndrome.
– Global collaboration agreement with Synta Pharmaceuticals Corp. for the joint development and commercialisation of STA-4783 in oncology.
– Worldwide alliance with Tolerx Inc. to develop and commercialise otelixizumab (TRX4), a novel humanised anti-CD3 monoclonal antibody. Collaboration focuses on type 1 diabetes and other autoimmune indications.
– Agreement with Merck for over-the-counter marketing rights for Mevacor in the U.S.
– Agreement with Sepracor Inc. for the commercialisation of eszopiclone product, treatment of insomnia, worldwide (excluding the U.S., Canada, Mexico and Japan).

2006
European Commission‘s approvals: Hycamtin as treatment for relapsed small cell lung cancer; Rotarix, allowing active vaccination of infants from the age of 6 weeks; quarterly intravenous injection of the osteoporosis medication Bonviva; Adartrel (ropinirole), for the treatment of moderate to severe idiopathic restless legs syndrome.
FDA‘s approvals: Avandaryl (rosiglitazone maleate and glimepiride), a new fixed-dose combination product for type 2 diabetes; a new formulation of Imitrex (sumatriptan succinate) injection; Flovent HFA (fluticasone propionate hfa) Inhalation Aerosol in children 4 to 11 years of age with asthma; Altabax (retapamulin ointment), 1%, for the treatment of secondarily-infected traumatic lesions; new use of the anti-seizure medicine Lamictal (lamotrigine) Tablets for the treatment of one of the most serious forms of epilepsy; Wellbutrin XL, for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder.
Roche and GSK announce FDA‘s approval of Boniva (ibandronate sodium) Injection, the first intravenous (IV) medication for the treatment of postmenopausal osteoporosis.
– GSK begins distribution of Trizivir (an HIV medicine) tagged with radio frequency identification (RFID) technology by IBM.
– Licence agreement with Simcere Pharmaceuticals to manufacture and sell products containing Zanamivir, in China and other countries, including all 50 of the world’s Least Developed Countries.
– Worldwide agreement with Genmab to co-develop and commercialize Arzerra and HuMax-CD20 (ofatumumab), a fully human monoclonal antibody.
– GSK and Adolor Corporation announce FDA‘s approval of Entereg (alvimopan 12mg) for the management of post operative ileus.
– GSK and Flamel Technologies announce FDA‘s approval of once-a-day Coreg CR (carvedilol phosphate) extended-release capsules for the treatment of 3 key cardiovascular conditions.
– Agreement with the Russian Government to supply anti-retroviral medicines, for the treatment of HIV/AIDS, at discounted prices.

2005-2000
– 2005: FDA approves once-monthly Boniva as the first once-a-month tablet for postmenopausal osteoporosis. GSK launches Rotarix, a vaccine against rotavirus, a major cause of vomiting and diarrhoea in infants.
– 2004: GSK ships 33 million tablets of preferentially-priced Combivir (HIV treatment) to Africa.
– 2003: 10 million people in Sri Lanka received free doses of Albendazole to help prevent the transmission of lymphatic filariasis. GSK launches Wellbutrin XL, an anti-depressant medicine, in the U.S.
– 2002: GSK donates the first 100 million Albendazole tablets for lymphatic filariasis. Avandia reaches 20 million prescriptions milestone in the U.S. GSK marks the 15th anniversary of AZT, the first medicine used to treat HIV/AIDS.
– 2001: Twinrix, the first combination vaccine to prevent hepatitis A and B is approved by the FDA. GSK launches Advair, an anti-asthma medicine, in the U.S. and acquires the Sensodyne range of oral care products. GSK launches the African Malaria Partnership.
– 2000: Avandia passes one million retail prescriptions in the U.S.

Consumer Brands
– Dermatological: Abreva, Eumovate, Hinds, Lactacyd, Zovirax.
– Vitamins and naturals: Abtei, Alluna, Beano, Cetebe, Feosol, Geritol, Granufink, Medacalm, Os-cal, Rutinoscorbin, Scott’s Emulsion, Valda, Viva, Vivarin.
– Weight loss: alli.
– Oral healthcare: Aquafresh, Astringosol, Binaca, Biotene, Chlorhexamed, Corega, Corsodyl, Dequadin, Dr. Best, Gly-Oxide, Macleans, Odol, Odol-med3, Parodontax, Polident, Polident 5 Minute, Poligrip Ultra, Sensodyne, Shumitect, Super Poligrip, Super Wernet’s, Synthol, Targon.
– Pain relief: BC Powder, Goody’s Powder, Iodex, Mejoral, Stanback.
– Allergy treatment: Beconase Allergy and Hayfever.
– Cold and flu treatment: Beechams, Coldrex, Iodosan.
– Respiratory: Breathe Right.
– Lip care: Chap-et.
– Analgesics and respiratory tract: Cholinex, Contac, Cortal, Crocin, Ecotrin, Fenbid, Panadeine, Panadol, Solpadeine.
– Analgesic/triptan: Formigran, Imigran Recovery.
– Gastrointestinal: Citrucel, Eno, FiberChoice, Gaviscon, Tagamet, Tums, Zantac.
– Smoking cessation treatment: Commit Lozenge.
– Nicotine replacement therapy: Committed Quitters, NiQuitin CQ/Nicoderm CQ/Nicabate, Nicorette.
– Ear care: Debrox.
– Eye care: Insto.
– Allergy treatment: Flixonase Allergy, Piriton.
– Anti-inflammatory: Hibitane.
– Nutritional healthcare: Horlicks, Lucozade, Maltova, Ribena.
– Nasal congestion: Libenar.
– Feminine hygiene: Massengill.
– Sleep aid: Nytol, Sominex.
– Gas: Phazyme.

Prescription Medicines
– A: Adartrel (ropinirole hydrochloride), Advair (salmeterol, fluticasone propionate), Albenza (albendazole), Alkeran (melphalan), Altabax (retapamulin ointment), Altargo (retapamulin), Amerge (naratriptan), Amoxil (amoxicillin), Andropatch (testosterone), Anectine (suxamethonium chloride), Argatroban (argatroban), Arixtra (fondaparinux sodium), Arranon (nelarabine), Arzerra (ofatumumab), Atriance (nelarabine), Augmentin (amoxicillin/clavulanate potassium), Avamys (fluticasone furoate), Avandamet (rosiglitazone/metformin HCl), Avandaryl (rosiglitazone maleate and glimepiride), Avandia (rosiglitazone maleate), Avodart (dutasteride), Axid (nizatidine).
– B: Bactroban (mupirocin), Becodisks (beclomethasone dipropionate), Beconase Aqueous Nasal Spray (beclomethasone dipropionate), Betnovate (betamethasone valerate), Bexxar (tositumomab), Boniva (ibandronate sodium).
– C: Ceftin (cefuroxime axetil), Coreg (carvedilol), Coreg CR (carvedilol phosphate), Cutivate (fluticasone propionate).
– D: Daraprim (pyrimethamine), Dermovate (clobetasol propionate), Dexedrine (dextroamphetamine sulfate), Digibind (digoxin antibody fab fragments), Doralese Tiltabs (indoramin hydrochloride), Dyazide (hydrochlorothiazide/triamterene), DynaCirc CR (isradipine).
– E: Efcortelan (hydrocortisone), Entereg (alvimopan), Eumovate (clobetasone butyrate).
– F: Flixonase (fluticasone propionate), Flixotide (fluticasone propionate), Flolan (epoprostenol), Flonase (fluticasone propionate), Flovent (fluticasone propionate), Fortaz (ceftazidime), Fortum (ceftazidime).
– H: Hycamtin (topotecan).
– I: Imigran (sumatriptan succinate), Imitrex (sumatriptan succinate), Imuran (azathioprine), Innopran XL (propranolol hydrochloride), Integrilin (eftifibatide).
– K: Kemadrin tablets (procyclidine hydrochloride).
– L: Lamictal (lamotrigine), Lanoxin (digoxin), Lanvis (tioguanine), Leukeran (chlorambucil), Liskonum (lithium carbonate), Lovaza (omega-3-acid ethyl esters).
– M: Malarone (atovaquone and proguanil hydrochloride), Mepron (atovaquone), Mivacron (mivacurium chloride), Myleran (busulfan).
– N: Naramig (naratriptan hydrochloride), Nimbex (cisatracurium besilate).
– O: Otosporin ear drops (polymyxin B sulphate, neomycin sulphate, hydrocortisone).
– P: Parnate (tranylcypromine sulfate), Paxil (paroxetine hydrochloride), Pentostam (sodium stibogluconate), Promacta (eltrombopag), Puri-Nethol (mercaptopurine).
– R: Relenza (zanamivir), Requip (ropinirole hydrochloride), Respontin nebules (ipratropium bromide), Rupafin (rupatadine fumarate), Rythmol (propafenone hydrochloride), Rythmol SR (propafenone hydrochloride).
– S: Septrin (co-trimoxazole), Seretide (salmeterol xinofoate, fluticasone propionate), Serevent (salmeterol xinafoate), Seroxat (paroxetine hydrochloride).
– T: Tabloid (thioguanine), Tagamet (cimetidine), Timentin (ticarcillin disodium / potassium clavulanate), Tracrium (atracurium besilate), Treximet (sumatriptan and naproxen sodium), Trimovate (clobetasone butyrate), Tykerb (lapatinib), Tyverb (lapatinib).
– U: Ultiva (remifentanil hydrochloride).
– V: Valtrex (valaciclovir hydrochloride), Ventolin (salbutamol sulphate), Ventolin HFA (albuterol), Veramyst (fluticasone furoate), Volibris (ambrisentan), Volmax (salbutamol sulphate), Votrient (pazopanib).
– W: Wellbutrin (bupropion hydrochloride), Wellvone (atovaquone).
– Z: Zantac (ranitidine hydrochloride), Zeffix (lamivudine), Zinacef (cefuroxime), Zinnat (cefuroxime axetil), Zofran (ondansetron hydrochloride), Zovirax (aciclovir), Zyban (bupropion hydrochloride), Zyloric (allopurinol).

Vaccines
– ACWY Vax: meningococcal polysaccharides serogroups A, C, W135 and Y.
– Ambirix: Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
– Boostrix: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed.
Cervarix: Human Papillomavirus vaccine (types 16, 18) – recombinant, adjuvanted, adsorbed.
– Engerix-B: Hepatitis B Vaccine (Recombinant).
– Fendrix: Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
– Fluarix: influenza vaccine.
– FluLaval: influenza vaccine.
– Havrix: hepatitis A vaccine, inactivated.
– Hepatyrix: Hepatitis A (inactivated, adsorbed) and Typhoid Polysaccharide vaccine.
– Hiberix: haemophilus B conjugate vaccine (tetanus toxoid conjugate).
– Infanrix: diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed.
– Infanrix IPV: diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed).
– Infanrix IPV + HIB: diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) and Haemophilus influenzae serotype b conjugate vaccine (adsorbed).
– Kinrix: diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine.
– Menitorix: combined Haemophilus influenzae type b and Neisseria meningitidis group C (Hib-MenC) conjugate vaccines.
Pandemrix: influenza vaccine (split virion, inactivated). Nano vaccine: particle size of AS03 (adjuvant) is 150-155 nm, side effects even on the DNA level.
– Pediarix: diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine combined.
– Poliomyelitis: poliomyelitis monodose vaccine live (oral).
– Priorix: measles, mumps and rubella vaccine (live attenuated virus).
– Rotarix: human rotavirus vaccine, live attenuated.
– Twinrix: combined hepatitis A (inactivated virus) and hepatitis B vaccine (genetically derived surface antigen).
– Typherix: typhoid vaccine (purified polysaccharide antigen).
– Varilrix: varicella in healthy adults and adolescents.

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