Amylin forges ahead with regulatory-approval efforts for Bydureon
SAN DIEGO Amylin Pharmaceuticals is pushing ahead in its effort to win approval for a long-acting Type 2 diabetes drug, according to a first-quarter earnings statement by the drug maker.
Amylin said it would submit a reply to the Food and Drug Administration this week for the complete response letter the agency sent to Amylin, Eli Lilly and Alkermes in March after reviewing their approval application for the drug Bydureon (exenatide), a long-acting version of the drug Byetta. The FDA issues a complete response letter when it finishes reviewing an approval application, but questions remain that preclude the application’s approval in its current form.
“With the submission of our Bydureon response this week, we are preparing to make this revolutionary treatment option available this year to the millions of patients living with Type 2 diabetes,” Amylin president and CEO Daniel Bradbury said.
The San Diego drug maker reported revenues of $174.1 million, with a net loss of $38.2 million, compared with a net loss of $47 million in first quarter 2009.
Drake University’s pharmacy college honors PTCB executive director, CEO
WASHINGTON Drake University’s College of Pharmacy has given its 2010 Lawrence C. and Delores M. Weaver Medal of Honor to the leader of a pharmacy technician group.
The Pharmacy Technician Certification Board announced Tuesday that executive director and CEO Melissa Murer Corrigan had received the medal, which the college, in Des Moines, Iowa, gives to individuals whom it considers to show dedication to the pharmacy profession. Murer Corrigan has served in her position at the PTCB since its 1995 inception.
“Under Melissa’s guidance and leadership, PTCB has positioned pharmacy technicians as an integral part of enhanced pharmacy practice and improved patient care,” American Pharmacists Association EVP and CEO Thomas Menighan said. “Trained, skilled pharmacy technicians empower pharmacists to spend time with patients to optimize their drug therapy and achieve the most positive outcomes possible.”
FDA adds boxed warning to propylthiouracil label
SILVER SPRING, Md. The Food and Drug Administration has added its strongest possible warning to a drug used to treat thyroid conditions amid reports of severe liver problems in patients using it, the agency announced Wednesday.
The FDA said it added a boxed warning to the label for propylthiouracil, a drug used to treat hyperthyroidism and Graves’ disease, conditions that cause goiters. The agency said it had received numerous reports of severe liver injury and acute liver failure, sometimes resulting in death, in adults and children.
The FDA approved the drug in 1947, and it is marketed as a generic. Pregnant women often use propylthiouracil during the first trimester due to possible risk of birth defects during that time from use of another drug for hyperthyroidism, methimazole, the FDA said. King Pharmaceuticals markets methimazole as Tapazole, though the drug also is available as a generic.