FDA issues guidelines for prospective makers of generic asthma, COPD drug
NEW YORK — A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.
The FDA guidelines, a set of non-binding recommendations released Monday, outline studies that manufacturers can conduct to determine equivalence between GSK’s Advair Diskus (fluticasone propionate; salmeterol xinafoate) and generic versions.
The main drug used in Advair Diskus loses patent protection in 2016, but it has been widely considered safer from generic competition than other drugs because it combines the drug and a device in the form of a special inhaler. According to the FDA guidelines, a generic drug company could theoretically win approval for a generic equivalent to the Advair Diskus if it develops an inhalation device that delivers the drug in a manner equivalent to the branded version.
Advair Diskus had sales of $4.9 billion, according to IMS Health.
La Roche-Posay’s commitment to sun safety education continues with SOS program
NEW YORK — Having performed more than 8,000 free skin cancer screenings all over the country, La Roche-Posay has been dedicated to raising awareness about the importance of sun safety with its annual SOS – Save Our Skin program over the past four years.
Through this initiative, the brand seeks to inform the public about upholding four commitments: Seek shade from 10 a.m. to 2 p.m., use the correct amount of sunscreen, reapply every two hours and receive annual skin checks. Throughout the spring and summer, La Roche-Posay instructed the public on sun safety through a variety of events, while also offering free skin checks in various locations nationwide.
In keeping with its mission of providing sun safety education for all, La Roche-Posay sought to engage all demographics, from elementary school students to men and women at every stage of life. In order to fulfill this goal, the SOS – Save Our Skin campaign featured a variety of events to reach as many people as possible throughout the country. The campaign was comprised of the following:
- To kick off the official start of summer on June 21, La Roche-Posay and the Women’s Dermatologic Society hosted the Parasols of Protection event in New York City’s Madison Square Park. The two-day "take-over" featured an art installation of colorful umbrellas suspended in the air to form a covered walkway through the park, underscoring the brand’s commitment to promoting safe sun practices. Board-certified dermatologists from the WDS provided more than 340 free skin checks, and Yankee starting player Brett Gardner made a surprise appearance and received a skin check. The event also featured an interactive digital wall to educate participants regarding key sun safe facts.
- Throughout the spring and summer, La Roche-Posay supported the efforts of dermatologists from the WDS who visited five elementary schools and a summer camp across the country to speak about sun safety as part of the Time Out, Protect Your Skin initiative. TOPS raises awareness about sun protection and instills good skin health habits for young children by integrating sun safety education into the curriculum at targeted schools.
- La Roche-Posay also sponsored the SELF Workout in the Park, an all-day and all-inclusive health and fitness event, in Washington, DC, New York City and Chicago. Board-certified WDS member dermatologists offered free skin checks and sun damage assessments, and visitors received free samples of La Roche-Posay Anthelios sunscreen. From yoga workouts to Pilates sessions to mini-spa services and hospitality tents, the events promoted a holistic approach to well-being;
- In an effort to further promote overall wellness, highlighting the link between skin cancer and breast cancer in collaboration with the WDS Play Safe in the Sun campaign, La Roche-Posay supported the outreach of local WDS members, who provided free skin checks, as well as literature and free samples of Anthelios sunscreen to those participating in the 15th Annual Komen St. Louis Race for the Cure. The race is the largest series of 5K runs/fitness walks in the world that raises funds for the local fight against breast cancer, celebrates breast cancer survivorship and honors those who have lost their battle with the disease;
- La Roche-Posay sponsored two Yankees games during the summer, providing free skin checks at Yankee Stadium. Board-certified dermatologists were on-site to provide the skin checks, and visitors also received free samples of La Roche-Posay Anthelios sunscreen; and
- The brand also joined forces with their retail partners nationwide, including Duane Reade and Ulta Beauty, to offer free skin checks with board-certified dermatologists and samples throughout New York City and across the country during the month of July.
With summer winding to a close, La Roche-Posay stated that it will continue its efforts to keep people protected year-round by donating Anthelios 60 Melt-In Sunscreen Milk samples to skin cancer awareness events all over the country throughout the fall and winter.
Actavis, Warner Chilcott shareholders approve merger deal
PARSIPPANY, N.J. — Shareholders of Actavis and Warner Chilcott have approved the merger of the two drug makers, the companies said Tuesday.
The deal, whereby U.S.-based Actavis will acquire Ireland-based Warner Chilcott, is expected to close later this year.
Actavis and Warner Chilcott announced the $8.5 billion deal in May. Last month, three independent proxy advisory firms recommended to shareholders that the deal go through, and most European regulators have approved it. Currently, it is still awaiting approval by the U.S. Federal Trade Commission and the Irish High Court.