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FDA approves APP Pharma analgesic injection

The US Food and Drug Administration (FDA) has approved APP Pharmaceuticals to market two dosage strengths of Clonidine Hydrochloride injection.

APP Pharma is a subsidiary of Fresenius Kabi Pharmaceuticals.

Clonidine Hydrochloride injection is used in conjunction with opiates to treat severe pain in cancer patients which is not adequately relieved by opioid analgesics alone.

The analgesic, which is the generic version of Astellas US’ Duraclon, will be rolled out in 1000mcg/10ml and 5000mcg/10ml single dose vials.

APP Pharma president and CEO John Ducker said the approval of APP’s Clonidine Hydrochloride further strengthens the company’s analgesic portfolio of products.