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Weekly Drug News Round Up - February 27, 2013

Pediatric Clinical Trials of Sensipar Halted After Report of Death

FDA has not determined if Sensipar had a role in the death, but will communicate their findings when available Read More...

The U.S. Food and Drug Administration (FDA) is notifying healthcare providers that all pediatric clinical trials of Sensipar (cinacalcet) have been stopped after the death of a 14-year-old patient. Sensipar is used to treat hyperparathyroidism and to lower calcium levels in people with cancer of the parathyroid gland. Sensipar is only approved for use in adults. Patients receiving Sensipar should be monitored for low serum calcium levels. If serum calcium levels decrease below the normal range, steps should be taken to increase calcium levels. Serum calcium levels should be measured within one week after initiation or dose adjustment of Sensipar, and then monthly after a maintenance dose is established.

Osphena Approved to Treat Painful Sex in Women

Osphena has estrogenic activity to build vaginal tissues and reduce pain during sex Read More...

The U.S. Food and Drug Administration (FDA) has approved Osphena (ospemifene), an oral estrogen agonist/antagonist with selective tissue effects, to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse). Dyspareunia is a condition that can result in thinner and drier vaginal tissues due to reduced levels of estrogen that occur during menopause. Generally, when estrogenic products are prescribed in postmenopausal women with an intact uterus, the combined use of a progestin should be considered to reduce the risk of endometrial cancer. Women should see their health care professional if they experience any unusual bleeding.

Kadcyla Approved Under FDA Priority Review Program

FDA’s priority review program is an expedited six-month process to offer therapy when limited alternatives exist Read More...

Kadcyla (ado-trastuzumab emtansine) has been approved by the U.S. Food and Drug Administration (FDA) as a treatment for HER2-positive, metastatic (late-stage) breast cancer. Kadcyla is intended for patients who were previously treated with trastuzumab, an anti-HER2 therapy, and taxanes, another class of chemotherapy drugs. In a clinical study of 991 patients randomly assigned to receive Kadcyla or lapatinib plus capecitabine, patients treated with Kadcyla had a median progression-free survival of 9.6 months compared to 6.4 months in patients treated with lapatinib plus capecitabine. The median overall survival was 30.9 months in the Kadcyla group and 25.1 months in the lapatinib plus capecitabine group.

Omontys Recalled Due to Life-Threatening Reactions

Omontys Injection is indicated for the treatment of anemia due to chronic kidney disease in adult patients on dialysis Read More...

The U.S. Food and Drug Administration, Affymax and Takeda Pharmaceutical Company are informing health care providers and the public of a voluntary recall of all lots of Omontys (peginesatide) injection due to reports of serious and fatal hypersensitivity reactions (anaphylaxis). Serious hypersensitivity reactions have been reported within 30 minutes of the first intravenous (IV) dose of Omontys. FDA reported 19 anaphylactic reactions, three of which resulted in death. Dialysis centers are instructed to discontinue use, and customers will be provided instructions on how to return the product to the manufacturer for a refund.

First-Time Generic Suboxone Okayed by FDA

Generic versions will be produced by Actavis and Amneal Pharmaceuticals Read More...

The U.S. Food and Drug Administration (FDA) has approved generic versions of Suboxone (Buprenorphine HCl and Naloxone HCl) sublingual (under the tongue) tablets. Suboxone is used for maintenance treatment of opioid (narcotic) dependence. Reckitt Benckiser produces Suboxone and Suboxone Film, a brand name of buprenorphine/naloxone in a sublingual form that is dissolved under the tongue. Generic equivalents of the tablet form are expected to be available immediately. Generics for Suboxone Film are not yet available. Suboxone tablets ranked 27th in the top 100 drugs by U.S. sales in Q4 2012.

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