Once again, Shire seeks FDA approval for Firazyr
DUBLIN — British drug maker Shire again is trying to win approval for a hereditary angioedema drug that the Food and Drug Administration had previously declined to approve.
Shire said Monday that it had submitted a response to the "not approvable letter" the FDA sent to German subsidiary Jerini AG in April 2008 for the drug Firazyr (icatibant).
The new application includes data that the agency had requested regarding the drug’s safety and efficacy. Approvable and not approvable letters sent by the FDA when it declines to approve a drug are now known as complete response letters.
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.