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Purdue’s hydrocodone bitartrate tablets granted priority review designation

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Hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5); also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5); a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine; and may be represented by the following structural formula:

Hydrocodone bitartrate Structural Formula Illustration

Hydrocodone Bitartrate
C18H21N03•C4H606•2.5 H20
Molecular weight = 494.5

 

Purdue’s hydrocodone bitartrate tablets granted priority review designation

Purdue Pharma has been granted priority review designation by the US Food and Drug Administration (FDA) for its hydrocodone bitartrate extended-release tablets for treatment of chronic pain.

The once-daily, single-entity pain medication was formulated to incorporate abuse-deterrent properties designed to make the product more difficult to manipulate for misuse or abuse by various routes of administration.http://www.pharmaceutical-technology.com/news/newspurdues-hydrocodone-bitartrate-tablets-granted-priority-review-designation-4313765?WT.mc_id=DN_News

 


Filed under: Priority review Tagged: hydrocodone bitartrate, priority review designation, Purdue

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