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FDA approves larger version of Oxytocin injection

The FDA has approved Abraxis Pharmaceutical Products's 30ml version of its Oxytocin injection, which is indicated for inducing labor.

Abraxis Pharmaceutical Products (APP) currently manufactures and distributes Oxytocin in 1ml and 10ml vials. The company will distribute the larger size in multi-dose vials with latex-free stoppers and expects to commence marketing of this product in the third quarter of 2007.

Oxytocin injection is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is also indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

APP is the hospital products business of Californian-based Abraxis Bioscience.