New Products: Rx, generics, OTC (December 2008)


A survey of new Rx, new OTC, new indications, and new generics


New Drugs

Sirion Therapeutics Inc. recently announced that Durezol (difluprednate ophthalmic emulsion) 0.05 percent is now available. Durezol, which was approved by the U.S. Food and Drug Administration (FDA) in June, is a topical ophthalmic corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery. Durezol is the first, and so far the only, steroid approved for treatment of both inflammation and pain. Visit for more information.

AstraZeneca announced the FDA has approved once-daily Seroquel XR (quetiapine fumarate) Extended-ReleaseTablets for the acute treatment of depressive episodes associated with bipolar disorder and manic and mixed episodes associated with bipolar one disorder, and as maintenance treatment of bipolar one disorder as adjunctive therapy to lithium or divalproex. Seroquel XR is the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder. Bipolar disorder, also known as manic depressive illness, is a serious psychiatric condition with recurring episodes of depression and mania. Approximately 8 million American adults may be affected by bipolar disorder. Visit for more information.

The FDA has granted Prezista (darunavir) tablets, a protease inhibitor, approval for an expanded indication for once-daily dosing as part of HIV combination therapy in treatment-naive adults (those who have never taken HIV medication before). The FDA also granted traditional (full) approval to Prezista for twice-daily use in treatment-experienced adult patients. Prezista is marketed in the United States by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P. Following this new approval, Prezista, co-administered with 100 mg ritonavir, and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Visit for more information.

New Generics

Teva Pharmaceutical Industries Ltd. announced that the FDA has granted approval for the company's ANDA for Fentanyl Transdermal System, 25 mcg per hour, 50 mcg per hour, 75 mcg per hour and 100 mcg per hour, the AB-rated generic equivalent of Ortho McNeil's chronic pain treatment Duragesic. The product uses a proprietary matrix design that incorporates the drug into the adhesive. It is indicated for the management of persistent moderate-to-severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and that cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids. Contact for more information.

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