FDA OKs Corifact
SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for a rare bleeding disorder.
The FDA announced the approval of Corifact, used to prevent bleeding in people with the genetic disorder congenital Factor XIII deficiency, which affects 1-in-3 million to 5 million people in the United States.
The drug is manufactured by Marburg, Germany-based CSL Behring.
NACDS, NCPA call pharmacy ‘backbone of Medicaid’s drug benefit’
ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association on Friday sent a joint letter to every governor and state Medicaid director on the importance of pharmacies in Medicaid and the industry’s interest in working with state governments to cut costs.
“Community pharmacies play a vital role in the Medicaid program as the backbone of its drug benefit,” wrote Steven Anderson, NACDS president and CEO, and Kathleen Jaeger, NCPA EVP and CEO. “Local pharmacists can provide expert medication counseling and other cost-saving services that help mitigate the $290 billion that is estimated to be spent on an annual basis as the result of patients who do not adhere properly to their medication regimen.”
The recommendations propositioned in the letter include:
- Advocating dispensing of generic medicines. Community pharmacy has a higher rate of generic dispensing (71%) than any other practice setting, including mail-order pharmacy, the letter stated;
- Incorporating medication therapy management services provided by pharmacists. The community pharmacist can provide critical advice and guidance to patients with chronic conditions, who very often need instruction and re-enforcement of optimal medication use, the letter suggested;
- For states considering adjustments to beneficiary cost sharing, NACDS and NCPA urged those governments to make co-payments mandatory as permitted under federal law. Requiring pharmacies to bear the costs of uncollected co-payments — which in some states is as high as 50% — is unfair, the associations argued, particularly at a time when there already have been significant reductions in pharmacy Medicaid reimbursement; and
- For states considering an average-acquisition-cost-based pharmacy reimbursement formula, NACDS and NCPA suggested undertaking comprehensive cost-of-dispensing studies and adjusting state dispensing fees, recognizing the importance of reimbursing pharmacies accurately for all aspects of providing prescriptions to Medicaid patients.
Impax granted FDA approval for generic Adoxa
HAYWARD, Calif. — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.
The drug maker on Friday said it received final approval of its abbreviated new drug application for doxycyline monohydrate capsules in the 150-mg strength. The drug, which is a tetracycline antibiotic used to treat bacterial infections, is a generic version of Adoxa. Adoxa is manufactured by PharmDerm, a Nycomed subsidiary.
Impax said its generic division, Global Pharmaceuticals, will launch the product.
U.S. sales of Adoxa in the 150-mg strength were approximately $25 million in the 12 months ended in December 2010, according to Wolters Kluwer.