News about "gDYANAVEL XR"

Granules Pharmaceuticals Secures US FDA Tentative Approval for gDYANAVEL XR

Granules Pharmaceuticals Secures US FDA Tentative Approval for gDYANAVEL XR

The tentative approval clears a key regulatory milestone for Granules Pharmaceuticals’ Abbreviated New Drug Application (ANDA), which the US FDA has determined to be eligible for 180-day market exclusivity.

GDYANAVEL XR | 09/01/2026 | By News Bureau


 

 

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