Injection

BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the first drug to be offered in the just-launched BD Simplist™ ready-to-administer, line of prefilled generic injectables. BD Simplist prefilled injectables will be commercialized and manufactured by BD Rx Inc., a wholly-owned subsidiary of BD.  The first BD Simplist product BD Rx will launch is Diphenhydramine Hydrochloride Injection, USP, an injectable antihistamine. 

BD Medical, a segment of BD, announced today that the BD Vystra Disposable Pen will be showcased at the 2012 Parenteral Drug Association Meeting in Las Vegas. This new self-injection pen has been designed for use with a wide range of therapies that require frequent, low-volume injections or variable dosing.

Studies suggest that as many as one-fifth to one-third of people with diabetes are hesitant or unwilling to give themselves insulin injections for reasons that include needle anxiety. Patients who reported injection-related pain or embarrassment also admitted they intentionally skipped insulin injections more often. A study by the American Association of Diabetes Educators (AADE) revealed that 47% of people with diabetes would be more likely to administer their injections regularly if a product were available that would ease the pain and discomfort of injections.

INJEX Pharma AG receives FDA clearance for the import and sale of the needle free injection technology INJEX 30 into the US Market

The FDA had registered INJEX Pharma GmbH, Berlin, and INJEX Pharma US, Miami, and given approval for the import and sale of INJEX 30 in the US market. The condition was the registration by the FDA for INJEX Pharma GmbH as manufacturer and exporter. This registration is now finalized.

Baxter International Inc. today announced the approval of ADVATE [Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency) in China by the State Food and Drug Administration (SFDA). It is estimated that more than 50,000 people in China are living with hemophilia A.

Hospira Inc. is initiating a voluntary user level recall of one lot of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30, due to a customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume.

Opioid pain medications such as morphine have life-threatening consequences if overdosed.  Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.