Recall of Liver Drug by CPIX - Analyst Blog

Recently, Cumberland Pharmaceuticals Inc. (CPIX) announced that it is recalling 6 lots of liver failure injection, Acetadote, on a voluntary basis. Acetadote is approved for counteracting overdoses of acetaminophen.

Cumberland Pharma also stated that the decision to recall 6 lots of the injectable drug was not because of any adverse event associated with the drug. The US Food and Drug Administration (FDA) has been informed of the decision.

The measure, undertaken by Cumberland Pharma, was only precautionary in nature. The lots were recalled due to the presence of some particulate matter in some vials of the liver therapy. The vials were manufactured by an ex-supplier of Cumberland Pharma. The voluntary recall of the 6 lots will have a limited impact on the supply of the drug.

We remind investors that last month, Cumberland Pharma suffered a huge blow when the US FDA refused to approve Acetadote, for an additional indication due to insufficiency of data. Acute liver failure is associated with a high mortality rate and liver transplantation is often needed to combat the disorder.

The US regulatory agency declined to approve Acetadote in patients with non-acetaminophen acute liver failure and issued a complete response letter (CRL). While issuing the CRL, the regulatory agency stated that there was insufficient evidence of efficacy in prolonging survival in patients suffering from acute liver failure. Management at Cumberland Pharma stated that it intends to meet the FDA regarding the objections raised by the FDA.

Apart from Acetadote, the other marketed products at Cumberland Pharma, which carries a Zacks #3 Rank (short-term ‘Hold' rating), are Kristalose, a prescription laxative and Caldolor (ibuprofen) for the treatment of pain and fever. The company competes with players such as Hospira Inc. (HSP).