BRIEF—FDA approval for Zydus for albendazole and pregabalin

India’s Zydus Cadila has received the final approval from the US Food and Drug Administration to market albendazole tablets 200mg.

It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.

This medication is used to treat certain tapeworm infections (such as neurocysticercosis and hydatid disease).

Zydus also received a tentative approval for pregabalin capsules in the strengths of 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg.

Pregabalin is the active ingredient of US pharma giant Pfizer’s best selling drug Lyrica, which generated third-quarter 2018 sales of $1.13 billion.

It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Pregabalin is used to help control certain kinds of seizures, painful nerve diseases and fibromyalgia.

Zydus group now has 239 approvals and has so far filed over 340 Abbreviated New Drug Approvals (ANDAs) since the commencement of the filing process in fiscal year 2003-04.