Zydus Cadila gets FDA OK for generic Robinul

The Food and Drug Administration has cleared Zydus Cadila’s glycopyrrolate injection in dosage strengths of 0.2 mg/mL and 0.4 mg/2 mL (0.2 mg/mL) single-dose vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) multiple-dose vials.

The medication is the generic of Robinul.

[Read more: FDA gives tentative nod to Zydus Cadila's generic Truvada]

Glycopyrrolate is used before surgery to decrease the volume of secretions from mouth, lungs and stomach; either before or during surgery to maintain heart’s normal beating rhythm; to counter the effects of some other medicines, which can slow heartbeat or produce excessive secretions when used during surgery; and in adults as an adjunctive therapy for the treatment of gastrointestinal ulcer when rapid effect is desired or when oral medication is not tolerated.

The drug will be manufactured at the group’s injectables manufacturing facility at CHL-Jarod, near Vadodara.

[Read more: Zydus Cadila gets FDA permission for generic Xeljanz]