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  • Antidepressant Pristiq¡¯s first generic seeks approval
  • by Lee, Tak-Sun | translator Byun Kyung A | Feb 13, 2020 06:27am
Generic with modified saline base applies for approval to MFDS on Feb. 6
Successfully evades patent infringement, immediate market release possible
 ¡ã Pfizer
Apparently, generic makers are knocking on the door of depression medication Pristiq ER tablet. This is the first time the original¡¯s saline base-modified drug is applying for an approval.

On Feb. 10, Korea¡¯s Ministry of Food and Drug Safety (MFDS) notified the Pristriq¡¯s patent holder Pfizer that a drug with desvenlafaxine, the original¡¯s active pharmaceutical ingredient (API), on modified saline base has applied for clearance on Feb. 6.

The original Pristiq ER tablet used succinate as a base, but the investigational drug has based the API on benzoic acid.

The generic¡¯s approval application has been predicted long before, as Pristiq¡¯s post-marketing surveillance (PMS) period of six years has expire
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