Takeda resubmits diabetes drug applications
DEERFIELD, Ill. — Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.
Takeda announced the resubmission to the Food and Drug Administration of applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in the Takeda drug Actos.
The applications were submitted after the company received a complete response letter from the FDA for the drugs in April. A complete response letter means that the agency has finished reviewing an application, but questions remain that preclude final approval. Takeda’s resubmissions include additional data from three phase-3 clinical trials that the FDA had requested.
Walgreens, HHS latest partnership continues to expand scope of retail pharmacy
WHAT IT MEANS AND WHY IT’S IMPORTANT — If you’re a student of pharmacy today, this is what you have to look forward to in the retail pharmacy setting: working with local, state and national health departments on creating market-driven disease state management programs; actually practicing what your professors have been preaching over the past six years; applying patient management skills over prescription adjudication skills; and making a real difference in your patients’ lives. If you’re not a student of pharmacy today, you should hurry up and enroll because you may have time to squeeze into the 2012 fall semester.
(THE NEWS: Walgreens develops MTM for HIV patients in pilot with HHS. For the full story, click here.)
This isn’t the first time at the make-retail-pharmacy-matter rodeo for either Walgreens or the Department of Health and Human Services. Both Walgreens and HHS have worked together on raising awareness that flu shots, along with a number of other vaccinations, are readily available at retail. Walgreens and HHS partnered on delivering free flu shots to underprivileged communities in December 2010 — pledging 350,000 flu shot vouchers to uninsured or underinsured Americans.
And in September 2011, Walgreens was one of the first pharmacy retailers to sign on with HHS on the Million Hearts program, a public-private sector initiative to prevent 1 million heart attacks and strokes in five years.
This also marks Walgreens’ continued foray into specialty pharmacy, specifically with regard to HIV management. In addition to Walgreens’ participation in the two-year pilot with the Centers for Disease Control and Prevention that will grow the role of the pharmacist in managing HIV, earlier this month, the D.C. Department of Health expanded its pharmacy network serving the District of Columbia’s AIDS Drug Assistance Program to include Walgreens.
But this is less about what one Chicagoland pharmacy retailer is doing in expanding the scope of pharmacy and more about how the role of retail pharmacist is evolving to meet the demands of health care today. Just what are those demands, though? I see the need for more healthcare touchpoints, a more ubiquitous access to healthcare consultations, if we’re ever to transform our national healthcare system from sick care to well care. (And subsequently, better control the costs of managing disease states.) I see these partnerships around flu, heart health and even HIV as first steps — helping to lay the foundation of pharmacy as a destination for all things health.
What do you think? How do you see the role of retail pharmacist evolving? And what are some examples you’re seeing out in the marketplace? Share your thoughts below, or email me at firstname.lastname@example.org.
Watson seeks approval for acne, bronchospasm drugs
PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection on a drug for acne and a drug for bronchospasm, the company said Monday.
Watson said it had filed a regulatory application with the Food and Drug Administration for a generic version of Galderma Labs’ Epiduo Gel (adapalene and benzoyl peroxide), a topical ointment for treating severe acne in patients ages 12 years and older. In response, Galderma filed suit against Watson on Friday in the U.S. District Court for the Northern District of Texas Dallas Division to prevent Watson from commercializing its product before the expiration of Galderma’s patents. Epiduo Gel had sales of about $199 million during the 12-month period ended in March, according to IMS Health.
The generis drug maker also filed an FDA approval application for legalbuterol tartrate inhalation aerosol, a generic version of Sunovion Pharmaceuticals’ Xopenox HFA, used to treat bronchospasm in patients ages 4 years and older with reversible obstructive airway disease. Sunovion filed suit against Watson on Friday in the U.S. District Court for the District of Delaware to prevent Watson from commercializing the drug. Xopenox HFA had sales of about $148 million during the 12-month period ended in March, according to IMS Health data.