Mylan Laboratories Inc said that the US Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals' Abbreviated New Drug Application for nitrofurantoin monohydrate/macrocrystals capsules, 100 mg. Nitrofurantoin is the generic version of Procter & Gamble's Macrobid.
Mylan was the first company to file a paragraph IV certification for nitrofurantoin, and as such is entitled to 180 days of marketing exclusivity.
Mylan intends to ship the product immediately.
Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Bertek Pharmaceuticals Inc., that develop, manufacture and market an extensive line of generic and proprietary products.