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FDA Approvals - FDA Adopts Interim Plan To Avoid Shortage Of Medically Necessary


FDA Adopts Interim Plan To Avoid Shortage Of Medically Necessary Opioid (Medical News Today)
The U.S Food and Drug Administration amended its March 30, 2009, action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis.

Oasmia: FDA Grants Paclical(R) Orphan Drug Designation For Ovarian Cancer In The USA (Medical News Today)
Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of Paclical(R) for the treatment of ovarian cancer. Orphan Drug designation can entail additional assistance from FDA to expedite and optimize drug development and upon approval a seven year market exclusivity is granted.
 

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