Drugs

CDER Drug Promotion Office Warns Shionogi

CDER’s Office of Prescription Drug Promotion (OPDP) has objected to a Shionogi “Patient Co-Pay Assistance Voucher” for Ulesfia (benzyl alcohol) lotion because it omits important risk information associated with the use of Ulesfia and omits material facts. As such, the voucher misbrands Ulesfia and makes its distribution violative, a just-posted Warning Letter to the firm says. Ulesfia is indicated for the topical treatment of head lice infestation in patients six months of age and older.

This is only the second letter from OPDP this year objecting to a drug firm’s promotional or advertising efforts. A letter was sent to Hospira in January that objected to a youtube.com video on Precedex (dexmedetomidine hydrochloride).

In the latest letter, OPDP notes that the voucher included the statements: “For more information on Ulesfia, please visit www.ulesfialotion.com” and “For more information, please refer to the package insert for full prescribing details or visit www.ulesfialotion.com.” However, the letter says these statements do not mitigate the omission of risk information from the voucher. “By omitting the risks associated with Ulesfia, the voucher fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome