FDA moves to address cancer drug shortages
SILVER SPRING, Md. — An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.
The FDA announced that it would address a shortage of the injectable Doxil (doxorubicin hydrochloride liposome) by allowing importation of Lipodox, an identical drug, by India-based Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Labs. The FDA said the measure was temporary and that such temporary importation of unapproved foreign drugs was considered in rare cases when there was a shortage of a critical drug. The shortage resulted from the closing of a manufacturing plant in Bedford, Ohio, owned by drug maker Ben Venue.
The FDA also gave expedited review to APP Pharmaceuticals’ preservative-free methotrexate, which it expects to become available in March. The drug is used to treat leukemia in children and osteosarcoma, as well as autoimmune disorders. In addition to the approval of APP’s version, Hospira is releasing 31,000 vials of the drug, enough to last a month, and the agency said it was working with Mylan, Sandoz and other companies to increase production.
Doxil is used in several treatment regimens, such as for ovarian cancer after treatment with platinum-based chemotherapy has failed, and also in patients with AIDS-related Kaposi’s sarcoma and multiple myeloma.
"A drug shortage can be a frightening prospect for patients, and President Obama made it clear that preventing these shortages from happening is a top priority of his administration," FDA commissioner Margaret Hamburg said. "Through the collaborative work of [the] FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need."
The FDA’s action is based on an executive order that President Obama made on Oct. 31, 2011, designed to address shortages of critical drugs. The FDA said the order and its own letter to manufacturers resulted in a six-fold increase in voluntary notifications of potential shortages by drug companies, with 114 shortages prevented since the order.
In addition to Tuesday’s approvals, the agency released draft guidance to the industry on detailed requirements for mandatory and voluntary notifications to the FDA on issues that could result in shortages and supply disruptions.
Pfizer inks generics deal with Chinese drug maker
NEW YORK — Pfizer has signed a deal worth more than $500 million with a Chinese drug maker to make generic drugs for China and other markets, the companies said.
Pfizer announced the joint venture with Zhejiang Hisun Pharmaceutical to develop, manufacture and commercialize generic drugs. Hisun will invest $295 million into the venture — called Hisun Pfizer Pharmaceutical Co. — and own a 51% stake, while Pfizer will invest $250 million and own 49%.
The signing of the deal took place at the Sino-U.S. Economy & Trade Forum in Los Angeles during the visit of Chinese vice president Xi Jinping, who is widely expected to become China’s next president when current president Hu Jintao steps down this year.
ReportersNotebook — Chain Pharmacy, 2/27/12
SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.
The FDA has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said. The FDA approved Novartis’ Gleevec (imatinib) for adults who have had gastrointestinal stromal tumors, or GIST, removed. The drug was specifically approved for people whose tumors are known as CD117-positive, which includes 95% of all GIST tumors. The drug was originally approved in 2001 for a type of leukemia.
Takeda Pharmaceutical has launched a drug for treating high blood pressure in adults, the company said. Takeda announced the availability of Edarbyclor (azilsartan medoxomil and chlorthalidone), a once-daily tablet for hypertension.
The FDA has approved a head lice treatment made by Sanofi, the drug maker said. Sanofi announced the approval of Sklice (ivermectin) lotion in the 0.5% strength for patients ages 6 months and older. According to Sanofi, head lice affects an estimated 6 million to 12 million children ages 3 to 11 years and costs as much as $1 billion in lost school days and lost work for parents.
The FDA has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said. Mylan announced that it had received tentative approval for a generic version of Pfizer’s Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths. A tentative approval means that the drug meets the FDA’s conditions for approval, but the agency can’t give final approval because of outstanding patent- and exclusivity-related issues. Ranbaxy Labs, which won approval for the first generic version of the drug in November, currently has the exclusive right to compete with Pfizer’s version and will until May. Lipitor had sales of $8.2 billion in 2011, according to IMS Health.