Endo's Par Pharma recalls one batch of its Remodulin generic over particulate concerns

2024-03-13

上市批准专利侵权优先审批生物类似药

Endo's Par Pharma recalls one batch of its Remodulin generic over particulate concerns

Preview

来源: FiercePharma

The recalled lot of treprostinil injection was distributed in 2022 and expires next month.

Endo’s Par Pharmaceutical is yanking one lot of its treprostinil injection from the U.S. market over concerns that silicone particles could be in vials of the drug.

The batch of the pulmonary arterial hypertension (PAH) drug expires next month and has been on the shelves since 2022 after it was distributed to wholesalers and hospitals from June to October of that year, the company said in a press release.

While Par has not yet received any reports of adverse events stemming from use of the recalled med, the consequences of particulate matter in an injectable could be dire. The impacts could range from irritation or swelling at the injection site to a stroke or even death if the particles reach the blood vessels and move to other organs.

The affected lot should immediately be discontinued from administration and distribution, Par said.

The company is issuing written notifications to customers who received the batch plus sorting out the return of the existing inventory.

Treprostinil for injection is a generic to United Therapeutics’ Remodulin, which has been marketed for over 20 years.

The drug, a prostacyclin vasodilator, is approved to reduce symptoms of PAH when used with exercise; it's also approved for patients who need to transition from tried and true PAH med epoprostenol. Remodulin is formulated for subcutaneous or intravenous infusion.

Meanwhile, it’s already been a busy month for U.S. drug recalls. A few days ago, the FDA disclosed a recall of more than 55,000 bottles of Sun Pharma's gout treatment febuxostat.

As for Par, its parent company Endo recently agreed to pay a bankruptcy settlement worth up to $464.9 million to the federal government after a Department of Justice investigation into its previous marketing of opioid painkiller Opana ER.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构