Mylan Laboratories Inc. has announced that the US FDA has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for modafinil Tablets, 100 mg and 200 mg.
Modafinil Tablets are the generic version of Cephalon Inc.'s Provigil Tablets.
Originally approved for the treatment of excessive daytime sleepiness associated with narcolepsy, today Provigil is said to be the only FDA-approved prescription medicine for treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder.