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US FDA Pushing For Generic Alternatives To Long-Acting Injectables, Implants

 
• By Joanne S. Eglovitch

Complexity of manufacturing process for long-acting polymer-based injectable drugs, implants and in situ forming gels is delaying development of generic alternatives, but the US FDA hopes that new research into the formulation of these drugs will shed some light on how manufacturing processes can be replicated.

FDA entrance sign 2016

The US FDA anticipates that new research will provide more insight on the processes used to manufacture long-acting polymer based implants and injectable drugs in order to spur generic drug development. Officials are concerned that the complexity posed in manufacturing these drugs is delaying the development of generic alternatives.

Called PLGA (polylactic co-glycolic acid) these are biodegradable polymers which are key components of long-acting release drug products. PLGAs can...

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