Content about Antiandrogens

February 23, 2012

The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

The FDA announced the approval of Menlo Park, Calif.-based Corcept Therapeutics' Korlym (mifepristone) for endogenous Cushing's syndrome, a disorder that results from overproduction of cortisol, a steroid hormone that increases blood-sugar levels.

August 30, 2011

The Food and Drug Administration has approved a treatment for dermatitis made by Perrigo under a collaboration with Chicago-based Cobrek Pharmaceutical.

ALLEGAN, Mich. — The Food and Drug Administration has approved a treatment for dermatitis made by Perrigo under a collaboration with Chicago-based Cobrek Pharmaceutical.

The drug maker said Tuesday that the FDA approved ketoconazole foam in the 2% strength. The drug is a generic version of Stiefel Labs' Extina, a topical drug used to treat seborrheic dermatitis in patients ages 12 years and older with healthy immune systems.

Extina has annual sales of about $10 million, according to Perrigo.

August 26, 2010

The Food and Drug Administration has approved a generic treatment for hypertension and liver cirrhosis...

HAUPPAUGE, N.Y. The Food and Drug Administration has approved a generic treatment for hypertension and liver cirrhosis made by Amneal Pharmaceuticals, Amneal said Thursday.

 

The FDA approved Amneal’s spironolactone hydrochloride tablets in the 25 mg, 50 mg and 100 mg strengths. The drug is a generic version of Pfizer’s Aldactone. Various versions of the drug had sales of $91 million in 2009, according to IMS Health.