Content about Omnitrope

October 11, 2011

The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths.

SUPPLIER NEWS — The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths. Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.


September 1, 2011

The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

PRINCETON, N.J. — The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

Sandoz, the generic drugs arm of Swiss drug maker Novartis, announced the approval of Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Turner syndrome. Sandoz said Omnitrope was now approved for all the same indications as the reference product, Pfizer's Genotropin.

August 26, 2010

The FDA approved Sandoz Omnitrope (somatropin [rDNA origin]) as a treatment for idiopathic short stature,...