Actavis seeks approval for additional strength of generic testosterone gel
PARSIPPANY, N.J. — Just a week after the Supreme Court heard the Federal Trade Commission’s lawsuit over its deal with AbbVie to sell a generic version of a testosterone-replacement therapy, Actavis is challenging the patent on another strength of the drug.
Actavis said Monday that it had filed with the Food and Drug Administration for approval of testosterone gel in the 1.62% strength. The drug is a generic version of AbbVie’s AndroGel 1.62%. The case that went before the Supreme Court on March 25 concerns the 1% strength of AndroGel.
AbbVie subsidiary Unimed Pharmaceuticals and another company, Besins Healthcare, filed suit against Actavis Friday in the U.S. District Court for the District of Delaware to prevent commercialization of the generic, alleging that Actavis’ FDA application violates a patent scheduled to expire in August 2020. The lawsuit puts a stay of FDA approval on the drug for up to 30 months, unless the companies reach a settlement.
AndroGel 1.62% had sales of about $690 million during the 12-month period that ended in January, according to IMS Health.
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FDA approves J&J diabetes drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Johnson & Johnson for treating Type 2 diabetes, the agency said.
The FDA announced the approval of J&J subsidiary Janssen Pharmaceuticals’ Invokana (canagliflozin) tablets, designed for use with diet and exercise to improve blood-sugar control in adults with the disease.
"Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 inhibitors," FDA Division of Metabolism and Endocrinology Products director Mary Parks said. "We continue to advance innovation with the approval of the new drug classes that provide additional treatment options for chronic conditions that impact public health."
The drug works by blocking the kidney from reabsorbing blood-sugar, also known as glucose, thereby increasing glucose excretion and lowering blood-glucose levels.
Expect flurry of legislative, provider activity on heels of new Calif. bills
Three bills that were introduced in California would recognize pharmacists as healthcare providers and would enable pharmacists, nurse practitioners and optometrists to practice to the full extent of their education and training.
The reality is that industry observers can expect to see more states considering similar measures as they all prepare a roadmap to lower costs by allowing pharmacists and NPs to practice at the top of their professions.
In fact, as previously reported by Drug Store News, lawmakers and other officials are taking notice and according to survey findings, so are HMOs. For example, the survey found that 75% of HMOs credential nurse practitioners as primary care providers, an increase over previous years. As the survey stated, there needs to be 100% credentialing in order “for the healthcare system to be ready for the huge influx of new patients in 2014. … All nurse practitioners must be able to practice to, and be compensated for, the full scope of their ability.”
The reason why this is critical is quite clear. First of all, there’s healthcare reform that will put roughly 30 million uninsured Americans into the coverage rolls come 2014, and then there’s the physician shortage in this country. It is estimated that the primary care physician shortage will reach about 60,000 by 2015.
According to numbers provided by the Convenient Care Association, as few as 2% of medical students coming out of U.S. medical schools intend to pursue a career in general primary care. Also, between 30% and 60% of patients of convenient care clinics — which are typically staffed by nurse practitioners — reported not having a primary care physician. Plus, as many as 40% of convenient care clinic patients said they would have sought costlier care or would have foregone care completely if there had not been a convenient care clinic available.
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