FDA actions in brief, September 2009 (Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, Kogenate FS)

Asenapine sublingual tablets (Saphris, Schering-Plough) were approved for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and for the acute treatment of schizophrenia in adults.

Bosentan (Tracleer, Actelion) was approved for the treatment of mildly symptomatic World Health Organization (WHO) functional class II pulmonary arterial hypertension.

Pitavastatin (Livalo, Kowa) was approved for the primary treatment of hypercholesterolemia and combined dyslipidemia.

The combination of aliskiren and hydrochlorothiazide (Tekturna HCT, Novartis) was approved as initial therapy for patients who are likely to need multiple drugs to achieve blood pressure goals.

Fentanyl buccal soluble film (Onsolis, BioDelivery Sciences/Meda) was approved for the management of breakthrough pain in patients with cancer aged ≥18 years who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

Teriparatide (rDNA origin) injection (Forteo, Lilly) was approved for the treatment of osteoporosis associated with sustained, systemic glucocorticoid therapy in patients at high risk of fracture.

Paliperidone extended-release injectable suspension (Invega Sustenna, Janssen) was approved for the acute and maintenance treatment of schizophrenia in adults.

Colchicine (Colcrys, Mutual) was approved for the treatment of acute gout flares and familial Mediterranean fever.

Ketorolac ophthalmic solution 0.45% (Acuvail, Allergan) was approved for the treatment of pain and inflammation after cataract surgery.

A combination of acyclovir and hydrocortisone (Lipsovir, Medivir) was approved for the topical early treatment of recurrent herpes labialis to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time.

A 3,000-IU vial size of antihemophilic factor (recombinant) (Kogenate FS, Bayer) was approved for the control and prevention of bleeding episodes and perioperative management in adults and children with hemophilia A and for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A who have no preexisting joint damage.