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Weekly Drug News Round Up - January 15, 2014

FDA Recommends Physicians, Pharmacists Enforce Lower Acetaminophen Doses

FDA recommends that the pharmacist contact the prescriber to discuss using lower doses of acetaminophen Read More...

In an effort to combat fatal liver damage, the U.S. Food and Drug Administration (FDA) is now recommending that health care providers prescribe combination drug products that only contain 325 mg or less of acetaminophen. Acetaminophen (Tylenol) is widely used as a prescription and over-the-counter pain and fever medication, and is often combined with ingredients such as cough and cold agents or opioids for pain. In January 2011 the FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen per tablet or capsule to 325 milligrams by January 14, 2014; not all manufacturers have complied.

Merck Recalls All Lots of Cholesterol Drug Liptruzet

The recall will deplete the available U.S. supply and stocks are expected to run out Read More...

Merck is voluntarily recalling all lots of Liptruzet (ezetimibe and atorvastatin) 10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg tablets in the U.S., including Puerto Rico, due to packaging defects. Some of the outer foil pouches may allow in air and moisture, which may affect drug potency or characteristics; although the likelihood is remote. The decision to recall Liptruzet was not based on any reported adverse experiences or product quality complaints. The medicine is not being recalled from patients or pharmacies. The two active ingredients in Liptruzet remain available: Zetia (ezetimibe), from Merck, and generic atorvastatin from multiple manufacturers. Merck will resume supplying Liptruzet, but the date is not known.

GSK’s Mekinist Plus Tafinlar FDA-Approved for Advanced Melanoma

The accelerated approval is contingent on the results of an ongoing Phase III trial Read More...

The U.S. Food and Drug Administration (FDA) has approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for the treatment of patients with aggressive melanoma that cannot be removed by surgery or that has spread to other parts of the body. This melanoma contains BRAF V600E or V600K mutations that must be detected by an FDA-approved test. The combination received Priority Review and was approved through the FDA’s Accelerated Approval program. In the Phase II trial, the median duration of response was 10.5 months for patients treated with the combination of drugs, and 5.6 months for patients treated with single-agent dabrafenib.

Telmisartan: Generic for Micardis Brand Now Available

Actavis intends to launch the product immediately

The U.S. Food and Drug Administration (FDA) has approved Actavis’ telmisartan immediate-release tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis. Actavis is eligible for 180 days of generic market exclusivity, which means prices may stay elevated during this period. Micardis is an angiotensin II receptor blocker indicated for the treatment of hypertension, to lower blood pressure and cardiovascular risk reduction in patients unable to take ACE inhibitors. For the 12 months ending September 30, 2013, Micardis had total U.S. sales of approximately $274 million, according to IMS Health data.

FDA: Dietary Supplements Cannot Treat Concussions

FDA regularly monitors the marketplace for false medical claims with supplements, and takes action to protect the public health Read More...

Concussions and other traumatic brain injuries (TBIs) have become a major area of concern for high school athletes, coaches and parents. The U.S. Food and Drug Administration (FDA) is now warning consumers that some dietary supplement providers are making false claims that their supplements can prevent concussions or promote faster healing time. Typically, products promising relief from TBIs tout the benefits of ingredients such as the spice turmeric and high levels of omega-3 fatty acids derived from fish oil. In December 2013, FDA issued a warning letter to Star Scientific, Inc., for marketing its product Anatabloc with claims to treat TBIs.