FDA Approves Mylan’s Generic of NuLytely

Mylan Inc. April 7 announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the Food and Drug Administration for its generic version of Braintree Laboratories’ NuLytely laxative.

NuLytely (polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride oral solution) had U.S. sales of approximately $31 million for the 12 months ending Dec. 31, 2009, according to IMS Health.

The Pittsburgh-based generic drug company said this product is available for immediate shipment. Mylan in late January announced that FDA approved its generic of another Braintree laxative, GoLytely (polyethylene glycol 3350 and electrolytes for oral solution).