CANONSBURG, Pa. (AP) — Mylan Inc. has received final U.S. regulatory approval to sell a generic version of the sleep disorder drug Provigil, and it plans to start sales immediately.
The Canonsburg, Pa., generic drugmaker said Friday that the Food and Drug Administration approved its application to sell 100-milligram and 200-milligram versions of modafinil tablets.
Mylan said in June it planned to start selling the generic versions in August under the terms of a settlement with Teva Pharmaceutical Industries Ltd., the company that makes Provigil.
Provigil is approved to treat tiredness caused by narcolepsy, obstructive sleep apnea and changes in work schedule. It was originally sold by Cephalon Inc. Teva bought Cephalon in October, and as part of that deal, antitrust regulators required that Teva sell the U.S. rights to generic Provigil to another company.
Par Pharmaceutical Cos. bought those rights and began selling a generic version of the drug in April.
The Food and Drug Administration ruled that Teva was the first company to file an application on two of the patents protecting Provigil. Mylan sued to gain marketing approval and exclusivity.
Mylan shares rose 12 cents to $23.42 in morning trading. They are approaching their 52-week high of $23.88 set in February.