New flu vaccines for 2013-2014 season and more

New flu vaccines

At the end of July, MedImmune, the biologics arm of AstraZeneca, began shipping FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) Nasal-Spray Flu Vaccine to U.S. distributors for the 2013-2014 influenza season. Eligible patients are children 2 years and older and adults through 49 years. The 2013-2014 influenza season is the first time that quadrivalent influenza vaccines will be available in the United States, protecting individuals against two strains of influenza A strains and two of influenza B. Previously, only trivalent influenza vaccines were available, which contained two strains of influenza A and one of influenza B. FluMist Quadrivalent Nasal-Spray Flu Vaccine will be available through private healthcare practices, public health departments, select retail pharmacies, school-located vaccination programs, military bases, and other sites. (www.flumistquadrivalent.com)

In July, GlaxoSmithKline (GSK) began shipping its first quadrivalent vaccine, Fluarix Quadrivalent for the 2013-2014 flu season. It will be available in pre-filled syringes. In August, GSK received FDA approval for FluLaval Quadrivalent (Influenza Vaccine Virus) for children 3 years and older and adults for the prevention of seasonal flu A and B strains. The FluLaval Quadrivalent vaccine will be available only in the United States, in limited amounts, and in multi-dose vials. GSK is taking order reservations for FluLaval Quadrivalent at its website, http://gskvaccinesdirect.com. In 2014, GSK will have increased capacity to supply substantial quanities of the two vaccines, which will be manufacturered in Quebec, Canada (FluLaval Quadrivalent) and Desden, Germany/Marietta, Pa. (Fluarix Quadrivalent). (www.gskvaccinesdirect.com)

Sanofi Pasteur, the vaccine division of Sanofi, shipped its first lots of its influenza virus vaccine for the 2013-2014 season at the end of July. Sanofi Pasteur offers four Fluzone options, including the Fluzone vaccine, the Fluzone quadrivalent vaccine, the Fluzone high-dose vaccine, and the Fluzone intradermal vaccine. (http://www.sanofipasteur.us/vaccines)

New drugs

In August, FDA approved Tivicay (dolutegravir) by GSK for the treatment of HIV-1 infection. This new integrase strand transfer inhibitor is a pill that is taken daily in combination with other antiretroviral drugs for HIV-infected individuals, including treatment-naïve and treatment-experienced adults, who may have been treated with other integrase strand transfer inhibitors. It is also approved for children who are 12 and older who weigh at least 40 kg, and have not been previously treated with other integrase strand transfer inhibitors. (http://bit.ly/tivicay)

Fetzima (levomilnacipran extended-release capsules) was FDA approved in July for the treatment of major depressive disorder in adults, according to Forest Laboratories. Fetzima is a serotonin and norepinephrine reuptake inhibitor, to be taken once daily. It is available in 40, 80, and 120 mg strengths. (www.FETZIMA.com)

New indication

The FDA has approved the alpha-2 adrenergic agonist brimonidine (Mirvaso) by Galderma to treat facial redness in adult patients with rosacea. The new indication makes Mirvaso 0.33% topical gel the first topical treatment specifically indicated for the persistent facial erythema of rosacea, according to a company statement. The gel is applied once daily to the face, and remains effective for up to 12 hours. The drug is thought to constrict dilated facial blood vessels, which reduces the redness in rosacea. (http://bit.ly/mirvaso)

New formulations

Actavis has launched new formulations of Fioricet (butalbital, acetaminophen, and caffeine capsules, USP) and Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate, USP) containing a lower dose of acetaminophen (reduced from 325 mg to 300 mg), designed to provide a safer treatment option for patients suffering from tension (or muscle contraction) headaches. Neither the total number of pills that may be prescribed, nor the time interval at which they may be prescribed, will change with the new formulations. (www.actavis.com)

New generics

Amneal is now shipping five new generic products, available through wholesalers, distributors, and directly to the trade. Potassium chloride extended-release capsules (therapeutically equivalent to Nesher’s Micro-K10 ExtenCaps) are available in 750-mg strength in counts of 100, 500 and 1000. Sildenafil tablets (therapeutically equivalent to Pfizer’s Revatio) are available in 20-mg strength in 90 count. Nevirapine tablets, USP (therapeutically equivalent to Boehringer Ingelheim’s Viramune), are available in 200-mg strength in 60 count. Metaxalone tablets (therapeutically equivalent to King Pharmaceuticals’ Skelaxin) are available in 800-mg strength in 100 count. Warfarin sodium tablets (therapeutically equivalent to Bristol-Myers Squibb’s Coumadin) are available in mg strengths of 1, 2, 2.5, 3, 4, 5, 6, 7.5, and 10 in 100 count. (www.amneal.com)

Dr. Reddy’s Laboratories has launched divalproex sodium extended-release tablets, USP (250 mg and 500 mg), a therapeutically equivalent generic version of Depakote ER Tablet. The 250-mg tablets are available in counts of 100 and the 500-mg tablets in 100 and 500 counts per bottle. (www.drreddys.com)