Salix issued CRL for Xifaxan
RALEIGH, N.C. — The Food and Drug Administration declined to approve a drug made by Salix Pharmaceuticals for irritable bowel syndrome, Salix said Tuesday.
The FDA issued a complete response letter to Salix for Xifaxan (rifaximin), a treatment for nonconstipation IBS and IBS-related bloating. Salix said it had anticipated that it would receive the letter based on an understanding that the agency needed more information related to retreatment.
A complete response letter indicates that the FDA has completed review of a regulatory approval application, but issues remain that preclude final approval. Salix said it planned to request a meeting with the agency to discuss the drug.
Allergan executive moves to CEO role at Hospira
LAKE FOREST, Ill. — Generic drug maker Hospira has appointed Mike Ball as CEO, effective March 28, the company said. Ball currently is president of Allergan.
Ball, who also was appointed to the company’s board, will replace Christopher Begley, who will assume the role of executive chairman.
“From the outset of our CEO search, the board and I were determined to identify a candidate who would extend Hospira’s growth trajectory, expand our global reach and inspire our employees as we continue our patient-focused journey to sustainable top-tier financial performance,” Begley said. “With his proven track record of growing complex global businesses, demonstrated success in leading diversified healthcare portfolios and strong commitment to creating value for all company stakeholders, we found the perfect fit with Mike Ball.”
New diabetes drug accepted for review by FDA
PRINCETON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a Type 2 diabetes drug from Bristol-Myers Squibb and AstraZeneca, the two drug makers said Tuesday.
The FDA accepted the application for dapagliflozin, an investigational drug for adults with the disease. The Centers for Disease Control and Prevention estimated that 1-in-11 U.S. adults has diabetes, with 90% to 95% of them having Type 2 diabetes.
The agency expects to take action on the application in late October.