Publication: Drugtopics.com

First reported May 23 2013 - Updated May 23 2013 - 1 reports

FDA panel green-lights lower doses of Merck’s sleep agent suvorexant

Soon after FDA expressed concerns over the higher dosages and safety profile, including daytime drowsiness, of the proposed sleep agent known as suvorexant (Merck), the Agency’s Peripheral and Central Nervous System Drugs Advisory Committee voted 13 to ... [Published Drugtopics.com - May 23 2013]

Entities: Suvorexant, FDA Food & Drug Administration, Insomnia, Drugs

First reported May 22 2013 - Updated May 23 2013 - 1 reports

National Association of Chain Drug Stores

NACDS opposes TRICARE changes

The National Association of Chain Drug Stores (NACDS) is urging a congressional panel to reject proposals that would force military families to use mail-order services to fill prescriptions.The panel, the House Armed Services Committee, is working on ... [Published Drugtopics.com - May 22 2013]

Entities: National Association of Chain Drug Stores, House Armed Services Committee, Military/Armed Forces

First reported May 22 2013 - Updated May 23 2013 - 1 reports

Sandoz recalls injectable methotrexate

Sandoz is conducting a voluntary nationwide recall at the U.S. hospital/user level of two lots of its injectable methotrexate sodium, USP, 25 mg/mL, 40 mL vials, as a result of the discovery of particulate matter during routine quality examination of ... [Published Drugtopics.com - May 22 2013]

Entities: Sandoz, Methotrexate, Ampoule, antimetabolite

First reported May 22 2013 - Updated May 22 2013 - 1 reports

FDA Food & Drug Administration

FDA approves first generic Atacand

Sandoz has become the first company to gain the FDA approval to produce a generic version of Atacand (candesartan cilexetil), the popular heart drug that generated an estimated 120 million in domestic sales last year.“Sandoz is proud to be the first generic ... [Published Drugtopics.com - May 22 2013]

Entities: Atacand, Sandoz, FDA Food & Drug Administration

First reported May 21 2013 - Updated May 22 2013 - 1 reports

Express Scripts Inc

Report: U.S. spending on specialty drugs to increase substantially

Spending on drugs used to treat cancer, multiple sclerosis, and rheumatoid arthritis will increase 67% by the end of 2015, according to a three-year forecast by Express Scripts.The report attributes the expected increases to the robust pipeline of new ... [Published Drugtopics.com - May 21 2013]

Entities: Drugs, Express Scripts Inc, Rheumatoid Arthritis, Multiple Sclerosis

First reported May 21 2013 - Updated May 22 2013 - 1 reports

Novel sleep agent suvorexant draws FDA concerns

The proposed sleep agent known as suvorexant (Merck), currently under consideration by FDA, differs from other agents already on the market, targeting sleep disturbances and insomnia by a novel mechanism that, if approved, would place it first in a new ... [Published Drugtopics.com - May 21 2013]

Entities: Suvorexant, FDA Food & Drug Administration, Drugs, Ambien

First reported May 22 2013 - Updated May 22 2013 - 1 reports

PCAB strengthens accreditation process

Beginning in September, the Pharmacy Compounding Accreditation Board (PCAB) will conduct unannounced surveys of compounding pharmacies seeking to renew accreditation from the group. The move is intended to further distinguish accredited compounding pharmacies ... [Published Drugtopics.com - May 22 2013]

Entities: Eric Everett, San Jose (San Jose, Costa Rica)

First reported May 22 2013 - Updated May 22 2013 - 1 reports

USPSTF advises against vitamin D, calcium to prevent fractures in adults

After its recent review, the U.S. Preventive Services Task Force (USPSTF) could not recommend vitamin D and calcium supplementation for the primary prevention of fractures in healthy adults.The USPSTF made its recommendations in the May 7, 2013, issue ... [Published Drugtopics.com - May 22 2013]

Entities: U.S. Preventive Services Task Force, Vitamin D, Calcium

First reported May 21 2013 - Updated May 21 2013 - 1 reports

Congressman pushes for ‘gray market’ reform bill

Congressman Elijah E. Cummings has introduced a bill to stop price gouging for drugs that are in short supply. He introduced H.R. 1958, The Gray Market Drug Reform and Transparency Act of 2013, on May 17.During the national drug shortage crisis, some ... [Published Drugtopics.com - May 21 2013]

Entities: Drugs, Short Supply, Wholesaler

First reported May 21 2013 - Updated May 21 2013 - 1 reports

Increased cardiac risks in COPD with new Rx inhalers

Older patients with chronic obstructive pulmonary disease (COPD) may be at increased risk for cardiovascular events with newly prescribed long-acting beta-agonists (LABAs) and long-acting anticholinergics (LAAs), and need to be followed closely by their ... [Published Drugtopics.com - May 21 2013]

Entities: Chronic Obstructive Pulmonary Disease, Inhalation, Anticholinergic, Patient

First reported May 21 2013 - Updated May 21 2013 - 1 reports

Abbott recalls FreeStyle InsuLinx glucose meters

Due to a recurring error that sometimes prompts FreeStyle InsuLinx Blood Glucose Meters to display false test readings, Abbott Diabetes Care has voluntarily recalled the product.At certain extremely high glucose levels, the FreeStyle meters store and ... [Published Drugtopics.com - May 21 2013]

Entities: Abbott Laboratories, Glucose, Diabetes, Blood Glucose

First reported May 21 2013 - Updated May 21 2013 - 1 reports

Actavis to buy Warner Chilcott for $8.5 billion in stock transaction

Actavis Inc. announced May 20 its plans to acquire Warner Chilcott in a stock transaction deal, which is worth approximately $8.5 billion. The merger is expected to create a global specialty pharmaceutical company serving the women’s health, gastroenterology, ... [Published Drugtopics.com - May 21 2013]

Entities: Warner Chilcott plc, Actavis, risedronate, Gastroenterology, Dermatology

Quotes

...pharmacy benefit for their members," said Glen Stettin, MD, Express Scripts’ senior vice president of clinical research and new solutions. "New specialty treatments are making a real difference in the lives of patients, but the very high cost of these drugs creates difficult decisions for plan sponsors on which medicines to cover."

Report: U.S. spending on specialty drugs to increase substantially [Published Drugtopics.com - May 21 2013]

"Based on these two recent decisions, we sense that FDA is setting a standard for how much effectiveness is required from the various tamper-proof mechanisms in order to delay the launch of generic alternatives,” said Cynthia Ambres, MD, partner and U S member of KPMG’s Global Healthcare Center of Excellence."

Endo’s petition to block generic forms of Opana ER thwarted by FDA [Published Drugtopics.com - May 14 2013]

"The FDA approval of Breo Ellipta brings an important inhaled, once-daily maintenance therapeutic option to COPD patients and doctors across the United States" Rick E Winningham, chief executive officer of Theravance, said in a company press release

Breo Ellipta for long-term treatment of COPD gets FDA nod [Published Drugtopics.com - May 14 2013]

"Once veterans are prescribed PPIs, they are very rarely taken off it"

High-dose PPIs prescribed for U.S. veterans with GERD [Published Drugtopics.com - May 10 2013]

More Content

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FDA panel green-lights lower doses of Merck’s s... [Published Drugtopics.com - May 23 2013]
NACDS opposes TRICARE changes [Published Drugtopics.com - May 22 2013]
FDA approves first generic Atacand [Published Drugtopics.com - May 22 2013]
Sandoz recalls injectable methotrexate [Published Drugtopics.com - May 22 2013]
PCAB strengthens accreditation process [Published Drugtopics.com - May 22 2013]
USPSTF advises against vitamin D, calcium to pr... [Published Drugtopics.com - May 22 2013]
Congressman pushes for ‘gray market’ reform bill [Published Drugtopics.com - May 21 2013]
Abbott recalls FreeStyle InsuLinx glucose meters [Published Drugtopics.com - May 21 2013]
Increased cardiac risks in COPD with new Rx inh... [Published Drugtopics.com - May 21 2013]
Report: U.S. spending on specialty drugs to inc... [Published Drugtopics.com - May 21 2013]
Novel sleep agent suvorexant draws FDA concerns [Published Drugtopics.com - May 21 2013]
Actavis to buy Warner Chilcott for $8.5 billion... [Published Drugtopics.com - May 21 2013]
Senators introduce revised draft compounding bill [Published Drugtopics.com - May 17 2013]
Bayer’s Xofigo wins FDA approval for treatment ... [Published Drugtopics.com - May 17 2013]
CDC issues new HCV guidelines [Published Drugtopics.com - May 16 2013]
HCV mortality rate high among younger people [Published Drugtopics.com - May 16 2013]
CV mortality risk not reduced by use of daily f... [Published Drugtopics.com - May 15 2013]
Better T2DM glycemic control achieved when phar... [Published Drugtopics.com - May 15 2013]
First study of patient satisfaction with a phar... [Published Drugtopics.com - May 15 2013]
Endo’s petition to block generic forms of Opana... [Published Drugtopics.com - May 14 2013]
Breo Ellipta for long-term treatment of COPD ge... [Published Drugtopics.com - May 14 2013]
Researchers find small benefit from antibiotics... [Published Drugtopics.com - May 13 2013]
NJ Board of Pharmacy offers guide to protect ag... [Published Drugtopics.com - May 11 2013]
Community pharmacists can bend medication adher... [Published Drugtopics.com - May 10 2013]
NACDS joins initiative to improve medication ad... [Published Drugtopics.com - May 10 2013]
Improved mental health seen with Medicaid cover... [Published Drugtopics.com - May 10 2013]
Better orthopedic surgery outcomes linked to ep... [Published Drugtopics.com - May 10 2013]
FDA warns against valproate use for migraine pr... [Published Drugtopics.com - May 10 2013]
NCPA advocates for PBM audit reform, greater tr... [Published Drugtopics.com - May 10 2013]
FDA approves first 4-factor PCC for warfarin re... [Published Drugtopics.com - May 10 2013]