NACDS outlines continued efforts in improving patient health to Senate committee
ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Thursday that it submitted comments to the U.S. Senate Health, Education, Labor and Pensions Committee, which held a hearing Thursday titled "FDA User Fees: Advancing Public Health," outlining community pharmacy’s commitment to addressing drug safety and the appropriate use of prescription medications to help improve patient health.
In its comments, NACDS outlined its continued efforts in improving patient health through the use of medication therapy management services, targeting illegitimate drug sellers, improving the communication of patient medication information and working with law enforcement to return and dispose of unwanted prescription medications.
"NACDS and the chain pharmacy industry support the goals of providing consumers with safe medications and working to prevent illegitimate Internet drug sellers from targeting U.S. consumers with unsafe medications. We also support providing patients with a useful and understandable drug information document (the "one document solution"), and providing patients with a safe and legal means for disposal of their unused medications," NACDS stated in its comments.
"In addition, we are devoted to important initiatives to improve patients’ adherence to their prescribed medications. Chain pharmacies and their pharmacists work with their patients daily to provide them with information and counseling on the proper use of their prescription medications and the importance of adhering to their prescription drug treatment," NACDS stated.
Watson launches generic Seasonique
PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.
Watson announced the launch of Amethia (levonorgestrel and ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]) after the U.S. Court of Appeals for the Federal Circuit denied Duramed’s request for a temporary injunction; a patent infringement lawsuit that Duramed filed against Watson remains pending.
The drug is a generic version of Duramed’s Seasonique, which had sales of about $110 million during the 12-month period ended in April, according to IMS Health.
Bydureon reply submitted to FDA
INDIANAPOLIS — Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes are giving their long-acting form of an injected drug for Type 2 diabetes another try at the Food and Drug Administration.
The three companies announced Thursday that they had submitted an official reply to the FDA, concerning the agency’s decision to not approve Bydureon (exenatide), an extended-release version of the drug Byetta. In October, the FDA delivered a complete response letter to the companies, meaning that it had completed review of the original regulatory application, but questions remained that precluded final approval.
The companies expect to receive a response from the FDA in the next two weeks, while review could take up to six months.