FDA Approves New Drug Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today (July 31) approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

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ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet

ETHEX Corporation announced today that it has voluntarily recalled to the consumer level, a single production lot of Hydromorphone HCl 2 mg tablets (Lot #90219, Exp: 03/2010; NDC #58177-0620-04), as a precaution, due to the possibility it may contain oversized tablets. Hydromorphone is a drug used for pain management and is packaged under the ETHEX label in 100-count bottles.

If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation.

There are other companies in the United States producing and marketing versions of Hydromorphone HCl tablets and consumers and their caregivers are encouraged to check their prescriptions to determine the source of their tablets. Hydromorphone HCl 2 mg tablets marketed by ETHEX are a blue, round tablet with a script "E" on one side and a "2" on the other side.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers nationwide who have received any inventory of the recalled lot of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact ETHEX as provided below regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call the telephone number below or their physician, pharmacist, or other health care provider.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472 or fax to ETHEX Customer Service at 314-646-3751, or e-mail to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST. Consumers who experience any adverse reactions to this drug should contact their physician and/or healthcare provider immediately. Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The Hydromorphone HCl recall announcement is posted on www.kvpharmaceutical.com and www.fda.gov/opacom/7alerts.html. It includes step-by-step details on how to return affected product to KV Pharmaceutical. The Company web site also includes a list of the drugs affected by the suspension.

The parent company of ETHEX Corporation, KV Pharmaceutical has advised the U.S. Food and Drug Administration that, effective midnight Dec. 19, 2008, the company voluntarily suspended shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to expeditiously address manufacturing issues that have come to management’s attention, to review and enhance comprehensively the company’s quality systems, and to implement efficiency improvements in its production facilities. KV is keeping the FDA informed about the Company’s plans.

This recall and suspension are being conducted with the knowledge of the FDA. At this time, the company is unable to determine when distribution of tablet form products will resume, or estimate what the financial impact of the recall and suspension will be.

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KV Pharmaceutical Voluntarily Suspends All Shipments of its Approved Tablet-form Drugs

KV Pharmaceutical has advised the U.S. Food and Drug Administration (FDA) that, effective midnight Dec. 19, 2008, the company voluntarily suspended all shipments of all FDA approved drug products in tablet form. KV Pharmaceutical is also recalling a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following the report of an oversized tablet. Additional details on this recall were provided in an ETHEX Corporation press release also issued today and will be posted on www.kvpharmaceutical.com.

At this time, the company is unable to determine when distribution of tablet-form products will resume.

A full list of products included in the suspension of shipments can be viewed on the Company’s website at www.kvpharmaceutical.com, where a link can be found on the home page to “Products Effected by Shipment Suspension”.

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ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets

ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

If someone were to take a higher than expected dose of Dextroamphetamine Sulfate, then the risk of adverse effects known to be associated with the drug such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth may be increased.

No report of any oversized Dextroamphetamine Sulfate tablets has been received by ETHEX from any wholesaler, retailer, consumer or caregiver, and ETHEX has not received any report of unexpected side effects or injury related to this product.

ETHEX Corporation is conducting this precautionary, voluntary recall because it found a small number of oversized tablets in lots which had not yet been distributed. These oversized tablets were removed before the lots were distributed.

Please be aware that there are multiple companies in the United States producing and marketing generic versions of Dextroamphetamine Sulfate 5 mg tablets and consumers and their caregivers are encouraged to check their prescriptions to determine the source of their tablets.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers nationwide who have received any inventory of the recalled lots of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact ETHEX as provided above regarding procedures for returning the recalled product. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized. If consumers have any questions about the recall, they should call the telephone number above, their physician, their pharmacist or other health care provider.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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