Matrix Labs’ gabapentin capsules get FDA OK
PITTSBURGH — The Food and Drug Administration has approved a treatment for shingles made by a subsidiary of generic drug maker Mylan.
Mylan announced Monday the approval of Matrix Labs’ gabapentin capsules in the 100-mg, 300-mg and 400-mg strengths. The drug is used to treat postherpetic neuralgia, a painful complication of shingles.
Gabapentin capsules had sales of about $300 million in 2010, according to IMS Health.
GSK granted FDA approval for Promacta
PHILADELPHIA — The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.
The drug maker announced the approval of Promacta (eltrombopag) for chronic immune thrombocytopenic purpura, or ITP, in patients who have not responded adequately to other therapies. Chronic ITP results in increased destruction of inadequate production of platelets in the blood, creating an increased risk of bruising and bleeding.
The FDA granted Promacta orphan drug designation in May 2008 and accelerated approval in November 2008.
Takeda’s Edarbi approved as hypertension treatment
SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for hypertension, also known as high blood pressure, the agency said Friday.
The FDA approved Takeda’s Edarbi (azilsartan medoxomil).
“High blood pressure is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” FDA Division of Cardiovascular and Renal Drug Products director Norman Stockbridge said. “High blood pressure remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”