Dr. Reddy’s launches generic Taxotere
BY Ryan Chavis
HYDERABAD, India — Dr. Reddy's Labs on Monday announced the launch of docetaxel injection USP in 20-mg and 80-mg dosage strengths. The drug is the generic version of Taxotere.
Taxotere brand and generic had sales in the United States of $218 million for the 12 months ending September 2014, according to IMS Health data. The drug is used to treat various types of cancer.
Dr. Reddy's docetaxel injection USP are available as a single dose, one-vial formula that doesn't require a prior dilution and is ready to add to the intravenous infusion solution, the company stated.
PQA endorses new performance measure
SPRINGFIELD, Va. — The membership of the Pharmacy Quality Alliance has endorsed a new performance measure, Statin Use in Persons with Diabetes, the group announced Friday.
This measure evaluates the percentage of patients ages 40 years to 75 years who were dispensed a medication for diabetes and who also receive a statin medication. It is based on the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. PQA member organizations had the opportunity to submit written comments regarding the newly developed and tested performance measure, participate in a phone conference hosted by PQA staff to discuss the measure and address questions, and, finally, to vote electronically on its endorsement. PQA reported that 90% of member respondents voted to endorse the Statin Use in Persons with Diabetes measure.
The National Quality Forum board of directors also announced on November 14 that it endorsed eight measures related to Patient Safety conditions, two of which are PQA measures. Overall, the eight NQF-endorsed Patient Safety measures focus on healthcare associated infections, including an ad hoc measure on sepsis, medication safety and general patient safety. NQF evaluated a total of 17 measures against their endorsement criteria; four new measures, 12 maintenance measures and one ad hoc measure were reviewed by the Consensus Standards Approval Committee. Additional information and a complete list of the 17 measures can be viewed on the NQF project page.
Purdue Pharma to launch abuse deterrent Hysingla ER (hydrocodone bitartrate)
STAMFORD, Conn. — Purdue Pharma on Thursday announced that the Food and Drug Administration approved Hysingla ER (hydrocodone bitartrate) extended‐release tablets CII, a once‐daily, single‐entity medication formulated using Purdue’s proprietary extended‐release solid oral platform, Resistec. It is the first and only hydrocodone product to be recognized by the FDA as having abuse‐deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection.
However, abuse of Hysingla ER by the intravenous, intranasal and oral routes is still possible.
Hysingla ER does not contain acetaminophen, the overuse of which has been reported to be a leading cause of acute liver failure in the United States. Prescription products containing hydrocodone and acetaminophen are both the most prescribed and among the most widely abused (nonmedical use) medications in the United States, Purdue Pharma noted.
“The burden of chronic pain and the abuse of prescription medications are both pressing societal problems,” stated Charles Argoff, professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in New York. “Opioids are an essential tool in our arsenal of medical treatments options, so greater availability and use of opioid analgesics with abuse‐deterrent properties has the potential to help alleviate suffering among people with chronic pain while reducing the abuse of these medications," he said. "Furthermore, this product gives treatment providers the option to use hydrocodone without acetaminophen if they are concerned that their patients may be taking too much acetaminophen on a daily basis.”
“We are proud to offer healthcare professionals and chronic pain patients another treatment option,” said Mark Timney, CEO of Purdue Pharma. “Hysingla ER is the third product in our pain management portfolio to receive an FDA label describing its abuse‐deterrent characteristics. These innovations are an important step forward in helping meet patients’ needs while also working to deter misuse and abuse.”
Purdue expects to launch Hysingla ER in the United States in early 2015 — in dosage strengths of 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120mg — to be taken once every 24 hours.
Hysingla ER is indicated for the management of pain severe enough to require daily, around‐the‐clock, long‐term opioid treatment and for which alternative treatment options are inadequate, the company stated. Hysingla ER is not indicated as an as‐needed analgesic. Hysingla ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, known or suspected paralytic ileus and gastrointestinal obstruction, and hypersensitivity to any component of Hysingla ER or the active ingredient, hydrocodone bitartrate.
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