Stiolto™Respimat®
(tiotropium bromide and olodaterol) Inhalation Spray
- Boehringer Ingelheim has launched once-daily Stiolto Respimat, a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
- It is the only COPD treatment with tiotropium, the active ingredient in Spiriva®, complemented by olodaterol
- Each unit contains one Stiolto Respimat cartridge and one inhaler. Each cartridge delivers 60 metered actuations. Each actuation delivers 2.5 mcg tiotropium and 2.5 mcg olodaterol
- For additional information visit www.stiolto.com
- Click here to order
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TIVORBEX™
(indomethacin) capsules
- Iroko Pharmaceuticals has launched TIVORBEX, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults
- TIVORBEX contains indomethacin as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. Click here for press release
- Each unit contains one Stiolto Respimat cartridge and one inhaler. Each cartridge delivers 60 metered actuations. Each actuation delivers 2.5 mcg tiotropium and 2.5 mcg olodaterol
- For additional information visit www.tivorbex.com
- Click here to order
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Xifaxan®
(rifaximin) 550 mg tablets
- Valeant is launching Xifaxan 550 mg tablets, FDA approved with a new indication to treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women
- Xifaxan (rifaximin) 550 mg was FDA approved in 2010 for reduction in risk of overt hepatic encephalopathy, a chronic worsening of brain function that occurs when the liver is not able to remove toxic substances from the blood
- Additionally, the FDA approved Xifaxan 200 mg in 2004 for the treatment of travelers' diarrhea caused by noninvasive strains of E. coli
- For additional information visit www.xifaxan.com
- Click here to order
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AEROSPAN™
(flunisolide 80 mcg) Inhalation Aerosol
- Meda has launched AEROSPAN™, a hydrofluoroalkane (HFA) orally inhaled corticosteroid indicated for the maintenance treatment of asthma as a prophylactic therapy in adult and pediatric patients 6 years of age and older
- AEROSPAN™ has shown in clinical studies to have a high deposition of the active drug flunisolide in the airways as a result of a built-in inhalation chamber called a "spacer"
- The dose delivered from the mouthpiece is 80 mcg flunisolide per actuation and there are 120 metered actuations per unit
- Click here to view Meda's press release
- Click here to order
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AKYNZEO®
(300 mg netupitant and 0.5 mg palonosetron) capsules
- Eisai has launched Akynzeo to treat nausea and vomiting in patients undergoing cancer chemotherapy
- Akynzeo is supplied as one capsule per blister card. The approved dosage is one capsule administered approximately 1 hour prior to the start of chemotherapy
- Click here for additional information
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ANORO™ ELLIPTA™
(umeclidinium 62.5 mcg and vilanterol 25 mcg) inhalation powder
- GlaxoSmithKline has launched Anoro Ellipta, the first once-daily U.S. FDA approved product that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Anoro Ellipta is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma
- Click here to view GSK's press release
- Click here to order
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BRINTELLIX™
(vortioxetine) 5mg, 10mg and 20mg tablets
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BREO™ ELLIPTA™
(fluticasone furoate 100 mcg and vilanterol 25 mcg inhalation powder) for Oral Inhalation
- GlaxoSmithKline has launched BREO ELLIPTA, a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist (LABA)
- BREO ELLIPTA is indicated for long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD)
- BREO ELLIPTA is supplied as a disposable light grey and pale blue plastic inhaler containing 2 double-foil strips, each with 30 blisters. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid (NDC 0173-0859-10). Each inhaler contains 30 doses
- Click here to order
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CONTRAVE®
(8 mg naltrexone HCl and 90 mg bupropion HCl) extended-release tablets
- Takeda has launched Contrave® as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
- Contrave is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
- Click here for additional information
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COPAXONE®
(glatiramer acetate) 40 mg injection
- Teva has received FDA approval and launched a 3-times-a-week Copaxone 40 mg/mL injectable therapy. This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis (MS)
- In addition to the newly approved dose, daily Copaxone 20 mg/mL will continue to be available. The daily subcutaneous injection was approved in 1996
- Click here for additional information
- Click here to view Teva's press realease
- Click here to order
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EPANED™
(enalapril maleate powder) for Oral Solution
- Silvergate Pharmaceuticals has received FDA approval and launched Epaned™ (enalapril maleate powder for oral solution)
- Epaned contains Enalapril, an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month, to lower blood pressure
- Epaned is the first FDA-approved oral solution for pediatric hypertension
- Parents can rely on the benefits of an FDA approved liquid formulation of enalapril compared to compounded formulations
- Epaned enables accurate dosing and has a taste that appeals to children, which may help to ensure compliance
- Elderly people that have trouble swallowing enalapril tablets may also benefit from Epaned
- Epaned is supplied as a kit: One bottle containing 150 mg of Epaned (enalapril) Powder for Oral Solution in an HDPE bottle with child-resistant cap to provide 1 mg/mL final concentration after reconstitution. And one bottle containing 150 mL of Ora-Sweet SF provided as the diluent for reconstitution
- For additional information visit www.epaned.com
- Click here to order
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EVZIO™
(naloxone HCI Injection) 0.4 mg auto-injector
- Kaleo, Inc. has launched EVZIO, the first and only FDA-approved naloxone auto-injector used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond.
- EVZIO contains the Intelliject® Prompt System (IPS?) with visual and voice instructions that are designed to make EVZIO easy to use for patients, their family members, and other caregivers
- For additional information please visit www.evzio.com
- Click here to view FDA’s news release
- Click here to order
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FYCOMPA® CIII
(perampanel) tablets
- Eisai has launched Fycompa™ (perampanel) tablets, a schedule 3 indicated as adjunctive therapy for the treatment
of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older
- Fycompa is the first and only FDA approved non-competitive AMPA Glutamate Receptor Antagonist. The drug's label carries a boxed warning, the strongest warning a drug can have, due to the risk of serious psychiatric and behavioral side effects
- For additional information visit www.fycompa.com
- Click here to order
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JARDIANCE®
(empagliflozin) tablets
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LANOXIN®
(digoxin) 62.5mcg (0.0625mg) and 187.5mcg (0.1875mg) tablets
- Covis Pharmaceuticals is launching two new strengths of brand Lanoxin® tablets: 62.5 mcg (0.0625 mg) and 187.5 mcg (0.1875 mg) in bottles of 100 count
- For the past several years, generic equivalents to Lanoxin (digoxin) have been on the market in the 125 mcg (0.125 mg) and the 250 mcg (0.25 mg) strengths. Therefore, Covis’ two new strengths will be: 1) half of the lowest generic strength available, and 2) In between the two generic strengths available on the market
- Covis brand Lanoxin product is approved for the treatment of mild to moderate heart failure in adults
- For additional information click here
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STRIVERDI® RESPIMAT®
(olodaterol) Inhalation Spray
- Boehringer-Ingelheim has launched Striverdi Respimat, a prescription medicine used long term, inhaled one time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD)
- Striverdi Respimat Inhalation Spray is available as 60 metered actuations (NDC 0597-0192-61)
- For additional information click here
- Click here to order
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TANZEUM™
(albiglutide) 30 mg or 50 mg for injection
- GlaxoSmithKline has launched TANZEUM (albiglutide) subcutaneous injection. TANZEUM is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- TANZEUM is supplied in a 30 mg single-dose Pen (carton of 4) or a 50 mg single-dose Pen (carton of 4)
- Click here to view FDA's news release
- Click here to order
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TRULICITY™
(dulaglutide) injection
- Eli Lilly has launched Trulicity (dulaglutide), a once-weekly injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes mellitus
- Trulicity is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that offers adults with type 2 diabetes once-weekly dosing in the Trulicity pen, which has a pre-attached, hidden needle and requires no reconstitution
- Trulicity must be stored in a refrigerator and will ship from Anda Monday - Thursday only
- Click here for additional information
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ZONTIVITY™
(vorapaxar) 2.08 mg tablets
- Merck has launched ZONTIVITY, indicated to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
- Zontivity is the first in a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist. It is an anti-platelet agent, designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing the formation of blood clots, Zontivity decreases the risk of heart attack and stroke.
- Click here to view FDA's news release
- Click here to order
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ZORVOLEX™
(diclofenac) capsules
- Iroko Pharmaceuticals has launched Zorvolex™ (diclofenac) capsules, the first lower dose Nonsteroidal anti-inflammatory drug (NSAID) using Solumatrix Fine Particle Technology™ for the treatment of mild to moderate acute pain in adults
- Click here to view Iroko's press release
- Click here to order
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