FDA releases list of 25 products to submit safety plans
WASHINGTON The Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy, the FDA said in a Federal Register notice published today.
Under the Amendments Act of 2007, FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.
“These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use,” said Jane Axelrad, associate director for policy, Center for Drug Evaluation and Research, FDA. “The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS.”
Some of the drugs on the list include: Biogen Idec’s multiple sclerosis drug Tysarbi, Celgene’s multiple myeloma medicine Thalomid, Roche’s severe acne treatment Accutane, and Cephalon’s pain medication Actiq.
ScriptPro robotic dispensing adopted in two Haggen locations
BELLINGHAM, Washington Haggen Food & Pharmacy has added ScriptPro’s robotic dispensing devices to two of its stores, one in Ferndale and the other in Barkley Village, according to published reports.
The system automatically selects a prescription vial, counts tablets or capsules into the vial and labels it with patient, drug and dosing information.
“This system offers many advantages for our customers,” said Andrew Charter, vice president of pharmacy at Haggen Inc. “It is better than partially automated systems in providing accurately counted doses. Most importantly, it frees up our pharmacists to spend more time answering the questions of customers rather than counting pills or making labels.”
Eli Lilly, Sanofi-Aventis partner to market Cialis
BRDIGEWATER, N.J. Sanofi-Aventis has agreed to help Eli Lilly market its impotency drug Cialis, according to CNN. Financial terms were not disclosed.
Lilly gained full rights to the medicine at the beginning of 2007, when it bought the drug from ICOS for $2.3 billion.
Cialis had worldwide sales of $1.1 billion in 2007, compared with its main competitor Pfizer’s Viagra, which saw sales of $1.76 billion.