BioCentury | Feb 1, 2020
Company News

Any chance left for safer opioids?

...language on the labels dissuades payers from reimbursing them. For example, the label for Embeda morphine/naltrexone...
...established. There is no evidence that the naltrexone in Embeda reduces the abuse liability of Embeda.”...
...abuse, a new formulation of the drug approved in 2013 with similar abuse-deterrent labeling to Embeda...
BioCentury | Nov 7, 2014
Politics & Policy

FDA unlikely to pull conventional opioids

...Woodcock said approved abuse-deterrent opioids are "version 1.0." FDA has approved three abuse-deterrent formulations, including Embeda...
BioCentury | Oct 20, 2014
Clinical News

Embeda morphine/naltrexone regulatory update

...FDA approved an sNDA from Pfizer to update the label of Embeda morphine/naltrexone to include a...
...are expected to reduce abuse via the oral and intranasal routes when it is crushed. Embeda...
...acquisition of King Pharmaceuticals Inc. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Embeda morphine/naltrexone ( ALO-01...
BioCentury | Oct 18, 2014
Company News

FDA approves abuse-deterrent labeling for Embeda

...FDA approved expanded labeling for Embeda morphine sulfate/ naltrexone hydrochloride extended-release capsules from Pfizer Inc. (NYSE:PFE...
...sulfate/ naltrexone hydrochloride extended-release capsules from Pfizer Inc. (NYSE:PFE) to include data from abuse-deterrent studies. Embeda...
...not completely prevent it. The agency is requiring postmarketing studies to evaluate the effects of Embeda's...
BioCentury | Aug 11, 2014
Clinical News

Morphine/naltrexone regulatory update

...3 months the PDUFA date for an sNDA seeking to expand the label of Embeda morphine/naltrexone...
...from abuse-deterrent studies. The PDUFA date is now in October 2014, it was in July. Embeda...
...with sequestered naltrexone. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Morphine/naltrexone ( Embeda ) ( ALO-01...
BioCentury | Aug 11, 2014
Clinical News

Embeda morphine/naltrexone regulatory update

...3 months the PDUFA date for an sNDA seeking to expand the label of Embeda morphine/naltrexone...
...from abuse-deterrent studies. The PDUFA date is now in October 2014, it was in July. Embeda...
...sulfate extended-release with sequestered naltrexone. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Embeda morphine/naltrexone ( ALO-01...
BioCentury | Nov 11, 2013
Clinical News

Embeda morphine/naltrexone regulatory update

...Pfizer said FDA approved an update to the manufacturing process of Embeda morphine/naltrexone for managing pain...
...March 2011 (see BioCentury, March 18, 2011). Pfizer expects to launch the product in 2Q14. Embeda...
...sulfate extended-release with sequestered naltrexone. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Embeda morphine/naltrexone ( ALO-01...
BioCentury | Sep 26, 2011
Product Development

Slow is good

...added to deter abuse. Examples include two Pfizer Inc. products: Embeda morphine/naltrexone and Oxecta oxycodone/niacin. Embeda...
BioCentury | May 2, 2011
Clinical News

Embeda regulatory update

...receiving Embeda. The agency is evaluating the reports to determine if regulatory action is needed. Embeda...
...Embeda through its acquisition of King Pharmaceuticals Inc. earlier this year (see BioCentury, March 7). Embeda...
...sulfate extended-release with sequestered naltrexone hydrochloride. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Embeda ( ALO-01...
BioCentury | Mar 28, 2011
Company News

Pfizer sales and marketing update

...Pfizer's King Pharmaceuticals Inc. subsidiary recalled all lots of pain drug Embeda in the U.S. because...
...as prescribed and also advised customers to continue their prescribed treatments until consulting a physician. Embeda...
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