FDA Launches Supply Chain Pilot Program

The U.S. Food and Drug Administration has launched the Secure Supply Chain Pilot Program (SSCPP) to enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drugs into the United States.

Hydroxyethyl Starch in Critically Ill Patients: The Verdict Is In

For resuscitation of patients with sepsis, the verdict is in: Hydroxyethyl starch products increase the risk of acute kidney injury and death.

New Boxed Warning Added to Immune Globulin Products

The U.S. Food and Drug Administration has instructed manufacturers to add information to the current boxed warning in the labeling of all intravenous immune globulin (IVIG) products, and add a similar standardized boxed warning for all subcutaneous and intramuscular IG products.

FDA Grants Expanded Indication Approval for CSL Behring’s Corifact

The U.S. Food and Drug Administration(FDA) has approved an expanded indication for CSL Behring’s Corifact, factor XIII (FXIII) concentrate (human) to include the perioperative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency.

FDA Approves VARIZIG for Treatment of Varicella Zoster Virus in High-Risk Patients

VARIZIG, a hyperimmune globulin indicated for post-exposure prophylaxis of varicella zoster virus (VZV) in high-risk patients, has been approved by the U.S.Food and Drug Administration.

FDA Approves Octaplas

Octapharma USA’s Octaplas, a solvent/detergent-treated pooled human plasma, has been approved by the U.S. Food and Drug Administration.

The Growing Scourge of Counterfeit Pharmaceuticals

Counterfeits pose a threat for healthcare professionals worldwide. And, while technological advancements are being made to protect the drug supply, international regulation and politics stand in the way of fixing the problem in the foreseeable future.

Reducing the Risks of Medication Errors

The federal government, physicians and consumers all have active roles to play in reducing medication errors that so often result in adverse drug events and a high cost burden.

Octapharma Initiative Expands Availability of Octagam 5%

Octapharma USA has started an initiative to make octagam (immune globulin intravenous [human] 5%), a therapy for primary immune deficiency, widely available to covered entities in the 340B Drug Pricing Program.

Study Shows New SCIG Drug Evogam Safe and Efficacious

Researchers investigated the efficacy, safety and pharmacokinetics and quality of life impact of Evogam, a new chromatographically fractionated 16% subcutaneous immunoglobulin (SCIG).