FDA approves Targiniq ER from Purdue Pharma
SILVER SPRING, Md. — The Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets). The drug is an extended-release, long-acting opioid analgesic that treats pain severe enough to require daily, long-term opioid treatment and as an alternative to treatment plans that have shown to be inadequate.
Targiniq ER has properties that are expected to deter, but not entirely prevent, abuse of the drug, the agency said. When the tablets are crushed and snorted, (or crushed, dissolved and injected,) the naloxone in the drug blocks the euphoric effects of oxycodone, making it less appealing to abusers than oxycodone alone.
"The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the United States,” said Sharon Hertz, M.D., deputy director of the division of anesthesia, analgesia and addiction products in the FDA’s Center for Drug Evaluation and Research. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”
The FDA is requiring postmarketing studies of Targiniq ER to assess serious risks, which include abuse, increased sensitivity to pain, addiction and overdose. The studies will also further examine the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER.
Targiniq ER is manufactured by Purdue Pharma.
Onco360 now part of limited distribution network for Zydelig
NEW YORK — Onco360, an independent oncology pharmacy and clinical support services company, announced that it has been selected to be part of the highly limited specialty pharmacy network of Zydelig tablets.
The Food and Drug Administration recently approved Zydelig for the treatment of three different B-cell blood cancers. It can be used in combination with rituximab for patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy; as monotherapy for patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior systemic therapies; and as monotherapy for patients with small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies.
“This selection is an important milestone in Onco360’s strategy to offer an innovative, diversified portfolio of pharmacy and clinical solutions,” said Burt Zweigenhaft, vice chairman of Onco360. “We have confidence in the potential of Zydelig to achieve a strong market share position and further bolster our leadership in the specialty oncology pharmacy market. This relationship also continues to enhance our mission of providing the highest level of support to those battling cancer and helping treat the unmet needs of thousands of people afflicted with life-threatening illness.”
Zydelig is immediately available for order through Onco360 and its network of OncoMed Pharmacies.
Supervalu off to ‘solid’ start for Q1
MINNEAPOLIS — Supervalu posted $5.23 billion in net sales for the first quarter, a decrease of 0.1% from $5.24 billion last year, though president and CEO Sam Duncan expressed confidence in the company’s performance, saying it is off to a solid start across business segments.
“Our first-quarter results reflect the investments we are making this year to position the company for future success, and I am pleased with our operating performance,” Duncan said.
Save-A-Lot’s net sales for the quarter were $1.35 billion, a 6.5% increase from $1.27 billion last year, driven by a network identical store sales increase of 5.6%. Identical store sales for corporate stores within the Save-A-Lot network were up 7.2%.
The company’s independent business net sales for the quarter were $2.4 billion, a decrease of 2.6% from $2.46 billion last year, primarily due to lost accounts, including lower sales to one New Albertson’s banner that completed the transition to self-distribution and lower military sales, partially offset by net new business.
Retail Food net sales for the quarter remained flat compared to last year’s $1.43 billion. Identical store sales were up 0.6%.
On March 21, 2013, the company completed the sale of five retail grocery banners — Albertsons, Acme, Jewel-Osco, Shaw’s and Star Market.
Supervalu operates 3,320 stores, which include 1,805 independent stores serviced primarily by the company’s food distribution business; 1,325 Save-A-Lot stores, of which 931 are operated by licensee owners; and 190 traditional retail grocery stores.