Actavis to acquire five products from Akorn/Hi-Tech Pharmacal
DUBLIN — Actavis on Friday announced that it has entered into agreements with Akorn and Hi-Tech Pharmacal to purchase four currently marketed products and one product under development for cash consideration. The closing of the purchase agreements are contingent upon the consummation of Akorn’s acquisition of Hi-Tech. Financial terms of the agreements were not disclosed.
The agreements include three products marketed under abbreviated new drug applications — ciprofloxacin hydrochloride ophthalmic solution, levofloxacin ophthalmic solution and lidocaine hydrochloride jelly — and one product marketed under a new drug application: lidocaine/prilocaine topical cream.
"The acquisition of these products will complement our expanding portfolio of topical and ophthalmic generic products, and further strengthen our position as a leader in developing and marketing the complex, high-barrier products that provide enhanced value," stated Siggi Olafsson, president of Actavis Pharma.
FDA approves Merck’s ragweed allergy remedy Ragwitek
WHITEHOUSE STATION, N.J. — Merck on Thursday announced that the Food and Drug Administration has approved Ragwitek (short ragweed pollen allergen extract) tablet for sublingual use (12 Amb a 1-U). Ragwitek is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis. Ragwitek is approved for use in adults ages 18 years through 65 years.
"Ragwitek provides a new sublingual approach to allergen immunotherapy for adult patients suffering from moderate to severe ragweed pollen allergies who have declined allergy shots," said David Skoner, director of the division of allergy and immunology for Allegheny Health Network and a clinical investigator in Merck’s sublingual allergen immunotherapy tablet program. "While there are regional variations, ragweed season typically starts in mid-August across the United States. During the season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication. These patients often have multiple sensitivities. To help prepare for the upcoming ragweed season, I would encourage patients diagnosed with ragweed pollen allergies to make an appointment now with an allergy specialist to discuss options."
Ragwitek is not indicated for the immediate relief of allergic symptoms.
Ragwitek is contraindicated in patients with severe, unstable or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
Symptoms of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis may include sneezing; a runny or itchy nose; stuffy or congested nose; or itchy and watery eyes, and typically intensify during the ragweed pollen season.
Ragwitek will be available in U.S. pharmacies by the end of April.
CDC: Evidence-based interventions reduces racial and ethnic health disparities
ATLANTA — Evidence-based interventions at the local and national levels provide promising strategies for reducing racial and ethnic health disparities related to HIV infection rates, immunization coverage, motor vehicle injuries and deaths, and smoking, according to a new report by the CDC’s Office of Minority Health and Health Equity released Thursday.
The report, published as an MMWR Supplement, describes CDC-led programs addressing some of the health disparities previously highlighted in the CDC Health Disparities and Inequalities Reports, CHDIR, 2011 and 2013. The CHDIR reports highlight differences in mortality and disease risk for multiple conditions related to behaviors, access to health care, and social determinants of health – the conditions in which people are born, grow, live, age and work.
"Reducing and eliminating health disparities is central to achieving the highest level of health for all people," stated CDC director Tom Frieden. "We can close the gap when it comes to health disparities if we monitor the problem effectively and ensure that there is equal access to all proven interventions."
Examples of the programs and health disparities addressed:
- The Vaccines for Children Program, managed by CDC, provides vaccines at no cost to eligible children who might otherwise not be vaccinated because of inability to pay. After the introduction of the VFC Program, racial/ethnic disparities in childhood immunization coverage do not exist for measles-mumps-rubella and poliovirus vaccines;
- Many Men, Many Voices is an evidence-based HIV/STD prevention intervention developed by and for black men that can lead to decreased rates of HIV infection and increased access to preventive services and treatment. It uses small group education and interaction to increase knowledge and change attitudes and behaviors related to HIV/STD risk among black men. In a randomized clinical trial, 3MV increased rates of HIV testing. The program has been implemented in 37 states, the District of Columbia and Puerto Rico and has been adapted to serve other men of color; and
- Four American Indian/Alaska Native tribal communities implemented tribal motor vehicle injury prevention programs, using evidence-based road safety interventions to reduce motor vehicle-related injuries and deaths. Each tribal community showed increased use of seat belts and child safety seats, increased enforcement of alcohol-impaired driving laws, or decreased motor vehicle crashes involving injuries or deaths. The effective use of communication tools –billboards, radio and television media campaigns, and school and community education programs– contributed to the success of this public health program.
"These interventions demonstrate progress toward health equity. They show the elimination of health disparities as an achievable goal and encourage further implementation of evidence-based initiatives and interventions addressing health disparities and inequities," reported Leandris Liburd, CDC’s associate director for Minority Health and Health Equity.