The US Food and Drug Administration (FDA) is providing information on the availability of doxorubicin hydrochloride liposome injection to supply the US market. Sun Pharma Global confirmed to FDA that sufficient supplies of its doxorubicin hydrochloride liposome injection, a generic product that is therapeutically equivalent to the Doxil, doxorubicin hydrochloride liposome injection distributed by Janssen Products LP and manufactured under contract by Ben Venue Laboratories. The manufactured announced it will cease manufacturing of Doxil by the end of 2013 due to manufacturing issues. The Sun Pharma Global product is indicated for the treatment of ovarian cancer and AIDS-related Kaposi sarcoma, in certain clinical settings.
FDA has asked the manufacturer of ponatinib (Iclusig) to suspend marketing and sales of the leukemia chemotherapy drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels. The drug manufacturer, Ariad Pharmaceuticals, has agreed to the FDA’s request. Ponatinib is used to treat chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). At this time patients and health care professionals should follow FDA’s new recommendations for the drug.
Hydrocodone bitartrate extended-release capsules (Zohydro ER) received FDA approval for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. A Schedule II controlled substance, the product is the first FDA-approved single-entity, extended-release hydrocodone product. The approved labeling and requirements for postmarketing studies are based on the requirements for all ER/LA opioid analgesics announced in September 2013. The most common side effects for Zohydro ER are constipation, nausea, drowsiness, fatigue, headache, dizziness, dry mouth, vomiting, and itching. The drug is manufactured by Zogenix Inc.
FDA plans to submit a formal recommendation to the US Department of Health and Human Services (HHS) to reclassify hydrocodone combination products, such as Vicodin, to a more restrictive schedule. The proposed change is from Schedule III to Schedule II, which would increase the controls on the drug. This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which FDA received input from a wide range of stakeholders.