FDA approves Hi-Tech Pharmacal epilepsy drug
AMITYVILLE, N.Y. — The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.
Hi-Tech announced the approval of levetiracetam oral solution in the 100 mg-per-milliliter strength. The drug is a generic version of UCB Pharma’s Keppra oral solution and is used to treat partial onset seizures in people ages 16 years and older.
Various versions of the drug had sales of $62 million in 2011, according to IMS Health. Hi-Tech said it plans to launch the drug in May.
Mylan launches generic version of Forest Labs’ Lexapro
PITTSBURGH — Mylan has launched a generic drug for treating depression and anxiety, the company said Wednesday.
Mylan announced the launch of escitalopram tablets in the 5-mg, 10-mg and 20-mg strengths, the first generic version of Forest Labs’ Lexapro. The drug is used for treating major depressive disorder and generalized anxiety disorder.
Lexapro had sales of about $2.9 billion in 2011, according to IMS Health. Mylan said it would market its version exclusively until Lexapro’s period of market exclusivity for use in children expires, according to an agreement between Forest Labs and Mylan’s Alphapharm subsidiary.
NCPA sends second letter addressing CMS’ double-billing of certain enrollment fees
WASHINGTON — The National Community Pharmacists Association last week sent a follow-up letter to the Centers for Medicare and Medicaid Services asking the agency to revisit a decision last month that effectively requires some pharmacies to pay duplicative fee-for-service Medicare enrollment/revalidation fees, according to the association.
The fee in question concerns CMS’ interpretation of a 2010 Affordable Care Act requirement where CMS is requiring Medicare provider/supplier enrollees to pay an enrollment/revalidation application fee twice, if the provider/supplier enrolls or revalidates through both an 855S and 855B enrollment/revalidation form for services or items, such as vaccinations and diabetes supplies. "These fees hit small independent pharmacies disproportionately who are already overly burdened in Part B by excessive accreditation fees, aggressive audits, and low payments," NCPA’s SVP government affairs John Coster wrote. "Pharmacies are simply at the breaking point with these additional dual revalidation fees," he added.
"CMS is in plain violation of the ACA statutory requirement on application fees and should revise the relevant regulation to require each institutional provider to pay a single application/revalidation fee, regardless of whether or not that provider has enrolled or revalidated using multiple 855 forms."
NCPA, along with the National Association of Chain Drug Stores, the Food Marketing Institute and the American Pharmacists’ Association, originally sent a letter addressing the situation in November 2011. CMS replied to that letter Jan. 19.