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FDA approves Spiriva HandiHaler (tiotropium bromide inhalation powder) for the long-term, once-daily maintenance treatment of bronchospasm associated with Chronic Obstructive Pulmonary Disease, which includes chronic bronchitis and emphysema, a lung disease primarily caused by smoking. Discovered and developed by Boehringer Ingelheim and co-promoted in the U.S. with Pfizer.
– Approval to market Inspra (eplerenone) in The Netherlands for the treatment of heart failure in patients who have had a recent heart attack.
– Approval from the European Commission to market Lyrica (pregabalin) for the treatment of peripheral neuropathic pain and as an adjunctive therapy for partial seizures in patients with epilepsy.
– Caduet (amlodipine besylate and atorvastatin calcium), the first single pill that treats both high blood pressure and high cholesterol, is launched.
FDA approves VFEND for treatment of serious bloodstream infections caused by Candida in nonneutropenic patients; Macugen (pegaptanib sodium injection), for the treatment of neovascular age-related macular degeneration, commercialized and developed with Eyetech Pharmaceuticals Inc.; Geodon (ziprasidone HCI), for the treatment of acute bipolar mania including manic and mixed episodes; Lipitor (atorvastatin calcium), for the prevention of cardiovascular disease; Zyrtec (cetirizine HCl) for the treatment of seasonal and perennial allergic rhinitis (inflammation of the nasal passages) and chronic idiopathic urticaria (itching and hives of unknown causes) in children aged two years and older; Zithromax, once-daily, three-day Treatment for Acute Bacterial Sinusitis.

– European approval of Aromasin, hormonal therapy for early breast cancer in postmenopausal women.
FDA approves Lyrica (pregabalin) to treat two distinct forms of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia and adjunctive treatment of partial onset seizures in adults with epilepsy; Aromasin, for adjuvant treatment of early breast cancer in postmenopausal women; Lipitor, to reduce the risk of stroke and heart attack in people with type two diabetes; CELEBREX for the relief of the signs and symptoms of ankylosing spondylitis, a form of arthritis that primarily affects the spine; Revatio (sildenafil citrate, active ingredient in Viagra), treatment for pulmonary arterial hypertension; depo-subQ provera 104 (medroxyprogesterone acetate injectable suspension), for the management of pain associated with endometriosis.

– The European Commission approves Exubera (inhaled human insulin) for the treatment of adults with type 1 and type 2 diabetes and Sutent (sunitinib malate) for advanced and/or metastatic renal cell carcinoma.
– Eraxis (anidulafungin), a new medicine to treat certain infections caused by Candida, a yeast-like fungus that can cause serious infections in hospitalized patients or patients with compromised immune systems, is launched.

– In response to Mylan Laboratories launching a generic competitor to Norvasc, Pfizer makes available its own generic amlodipine besylate product through the company’s Greenstone subsidiary.
FDA approves Maraviroc, a therapy for treatment-experienced patients infected with CCR5-tropic HIV-1; Lyrica (pregabalin) capsules CV, for the management of fibromyalgia; Cerenia (maropitant citrate), the first and only medication for the prevention and treatment of canine vomiting; Selzentry, for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 detectable; Dalbavancin, once-weekly two-dose antibiotic for the treatment of adult patients with complicated skin and skin structure infections.

FDA approves Convenia (cefovecin sodium), the first and only antibiotic for dogs and cats available in a single veterinarian-administered injectable dose, and TOVIAZ (fesoterodine fumarate), for the treatment of overactive bladder.
– License and supply agreement with Sigma-Tau, Italian pharmaceutical company, to market Eurartesim, a potential new treatment for malaria in Africa. The product is developed jointly by Medicines for Malaria Venture and Sigma-Tau.

European Commission approves swine vaccine, Improvac, against boar taint.
FDA approves first canine cancer therapy.
FDA approval of Geodon (ziprasidone HCI) Capsules, for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults; Revatio (sildenafil) Injection, intravenous formulation of Revatio, the only FDA-approved phosphodiesterase-5 inhibitor available in both tablet and intravenous formulations indicated for the treatment of adult patients with pulmonary arterial hypertension.
– The European Commission grants marketing authorization for pneumococcal conjugate vaccine, Prevenar 13* (Pneumococcal Polysaccharide Conjugate Vaccine, 13-valent, adsorbed), indicated for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by 13 Streptococcus pneumoniae serotypes in infants and children from 6 weeks to 5 years of age. Invasive pneumococcal disease includes sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema. Prevenar 13, built on the scientific foundation of Prevenar* (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), provides the broadest serotype coverage of any pneumococcal conjugate vaccine, including the 7 serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevenar plus 6 additional serotypes (1, 3, 5, 6A, 7F, and 19A), which together represent the most prevalent invasive disease-causing strains in young children worldwide. Prevenar 13 is the only pneumococcal conjugate vaccine to include serotypes 3, 6A, and 19A. Both Prevenar and Prevenar 13 use CRM, a carrier protein used in various approved pediatric conjugate vaccines for more than 20 years. Available in Europe since 2001, Prevenar is available in more than 100 countries and more than 300 million doses have been distributed worldwide. In the European marketing authorization, the schedule recommended for Prevenar 13 consists of 4 doses, 3 primary doses, followed by a booster dose between 11 and 15 months of age. Alternatively, when Prevenar 13 is given as part of a routine infant immunization program, Prevenar 13 may be administered as a 3 dose series, 2 primary doses followed by a booster dose. Infants and children who have begun immunization with Prevenar may switch to Prevenar 13 at any point in their dosing schedule. It is also recommended that children up to 5 years of age who have completed vaccination with Prevenar should be offered coverage against the six additional serotypes included in Prevenar 13.
Pfizer Animal Health announces Swine Influenza Vaccine, pH1N1 – Killed Virus, approval by the U.S. Department of Agriculture for vaccination of healthy swine, including pregnant sows and gilts, 3 weeks of age or older against SIV subtype H1N1.
Boehringer Ingelheim Pharmaceuticals Inc. and Pfizer Inc. announce FDA approval of SPIRIVA HandiHaler (tiotropium bromide inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease.


– William R. Warner launches his own drug store in Philadelphia, Pennsylvania.

– Gives up and then focuses solely on drug manufacturing under the name William R. Warner & Co.

Jordan Wheat Lambert launched Lambert Pharmacal Company in St. Louis. Main product was Listerine antiseptic, marketed only to medical professionals. Lambert soon realized that Listerine had huge consumer marketing potential, and in 1914, began to mass-market Listerine through an advertising campaign that is still a case model in business schools.

Pfeiffer Chemical, St. Louis-based company, buys William R. Warner & Co., keeps the Warner name, and expands the company through acquisition.

– Creation of the Warner-Lambert Pharmaceutical Company.

– Acquisition of American Chicle Company, New York City-based company among the world’s largest producers of gums and mints. American Chicle‘s flagship brand name, Adams, was well known around the world and its products included Dentyne, Chiclets and Trident gums, and Certs and Clorets mints.

– Acquisition of a small cough tablet company in the United Kingdom, expanding the brand known as Halls Mentholyptus to global stature.

– Acquisition of the Schick wet-shave product line from Eversharp, company founded in 1929 by Jacob Schick, whose magazine-loading razor was inspired by the repeating rifle.
– Acquisition of Parke-Davis, once the world’s largest drugmaker. Parke-Davis traces its history back to 1866, when Hervey Parke and George Davis formed a small company in Detroit, Michigan. They pioneered the standardization of medications and built the first modern pharmaceutical laboratory. They also developed the first organized, systematic method of clinically testing new drugs. In the first half of the 20th Century, Parke-Davis introduced a number of breakthrough products, including the first bacterial vaccine, a pure form of adrenaline, and Dilantin (phenytoin), the first widely available treatment for epilepsy and seizure. Dilantin remains a valuable therapy against convulsions. After World War II, Parke-Davis popularized a number of anti-infectives, developed the Salk polio vaccine for widespread use, and introduced a new line of oral contraceptives.

– Acquisition of Wilkinson Sword, combining it with Schick to create the world’s second largest wet-shave business, currently owned by Energizer Holdings.

– Co-marketing agreement with Pfizer on Lipitor (atorvastatin calcium), a new entry into the statin class of lipid-lowering agents. Discovered by Parke-Davis Research and introduced in 1997, Lipitor is the largest-selling pharmaceutical of any kind worldwide ($12.9 billion sales in 2006).

– Acquisition of Agouron, leader in protein-based drug design and marketer of the protease inhibitor, Viracept (nelfinavir mesylate).
– The University of Michigan receives $5 million from the Parke Davis Pharmaceutical Research Division of Warner-Lambert Company to help the University establish a new Program in Bioinformatics. Bioinformatics merges advances in molecular biology and genetics with advanced computer science technology. The goal is increased understanding of the complex web of interactions linking the individual components of a living cell to the integrated behavior of the whole organism.

– Merged with Pfizer.

Warner-Lambert used activities not usually associated with sales promotion, including continuing medical education and research, sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within 5 years the drug was being widely used for the off-label treatment of pain and psychiatric conditions. In 2004, Warner-Lambert admitted to charges that it violated FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses, and paid $430 million to resolve criminal and civil health care liability charges. Today it is a mainstay drug for migraines, even though it was not approved for such use in 2004.


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