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FDA has approved saxagliptin and metformin extended-release (XR) (Kombiglyze XR, AstraZeneca/Bristol-Myers Squibb) tablets for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin XR plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across glycosylated hemoglobin levels, fasting plasma glucose, and postprandial glucose.

FDA has approved acetaminophen injection (Ofirmev, Cadence Pharmaceuticals), the first intravenous (IV) formulation of acetaminophen for the management of mild-to-moderate pain, moderate-to severe-pain with adjunctive opioid analgesics, and the reduction of fever.

FDA has issued a complete response letter (CRL) for lorcaserin's (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese or patients who are overweight and have at least 1 weight-related co-morbid condition.

OnabotulinumtoxinA (Botox, Allergan) has been approved by FDA as prophylactic treatment of headaches in adults with chronic migraine. It is the first clinically studied prophylactic treatment to receive FDA approval specifically for this debilitated patient population.

Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has received FDA approval for the prevention of stroke and blood clots in patients with atrial fibrillation. It is the first replacement for warfarin to win FDA approval.

"Know Your Medicine, Know Your Pharmacist" is the theme of American Pharmacists Month (APhM). Sponsored by the American Pharmacists Association, APhM is a time to recognize the significant contributions to healthcare made by pharmacists around the country.

The National Institutes of Health awarded ScriptPro a contract to provide pharmacy automation systems to assist in the internal control and identification of drugs and to enhance the safety and efficiency of medication dispensing as well as use by patients.

OTC Product News

With this issue of Drug Topics' e-newsletter, we expand our OTC Product Update page to showcase products and product news that fell outside the parameters of recently featured categories or ran up against space limitations in the print edition. Look for more OTC Product News in upcoming issues of the Drug Topics e-newsletter!

Pfizer plans to acquire King Pharmaceuticals for $3.6 billion in cash, expanding its current portfolio of treatments for pain relief and pain management.

Taking Care of Myself: A Guide for when I Leave the Hospital/Como cuidarme: Guia para cuando salga del hospital, is a new, bilingual guide produced by the Agency for Healthcare Research and Quality (AHRQ), to help hospitals reduce their rates of readmission by better preparing patients before they leave the hospital.

Implementation of a policy restricting drug sampling and pharmaceutical industry detailing in a small rural clinic resulted in modest reductions in the prescription of branded and promoted drugs, according to research published in the September/October issue of the "Annals of Family Medicine."

Use of Schedule II opioids, back pain, headache, and pre-existing substance use disorders are all associated with alcohol- or drug-related encounters and emergency department visits in adults who have taken prescribed opioids for at least 90 days, according to a study published in the Sept. 13 issue of the Archives of Internal Medicine, HealthDay News reports.

The updated International Society on Hypertension in Blacks consensus statement on the management of hypertension in this population places a major emphasis on comprehensive assessment and appropriate risk stratification of individual patients with hypertension, according to a report published online Oct. 4 in Hypertension and reported by HealthDay News.

Individuals with ocular herpes simplex virus treated with prophylactic oral antibiotics appear to be at a lower risk of recurrence of epithelial keratitis, stromal keratitis, conjunctivitis, and blepharitis, according to research published in the September issue of the Archives of Ophthalmology, HealthDay News reported.