Mylan Receives Approval for Phenytek; Bertek Pharmaceuticals Inc. to Offer Convenient, New "Once-Daily" Capsule FDA Affirms Bioequivalence to Dilantin Kapseals

Business Wire, Dec 6, 2001

Business Editors and Medical/Health Writers

PITTSBURGH--(BUSINESS WIRE)--Dec. 6, 2001

Mylan Laboratories Inc. (NYSE: MYL), today announced that it has received U.S. Food and Drug Administration (FDA) approval of the anticonvulsant Phenytek(TM), extended phenytoin sodium capsules in 200 mg and 300 mg strengths.

In approving Phenytek, the FDA affirmed that Mylan's product is bioequivalent to Dilantin(R) Kapseals(R), which are manufactured by Pfizer's Parke-Davis division.

Mylan's Bertek Pharmaceuticals subsidiary will begin offering the new 200 mg and 300 mg capsules in December. The new product will be among the first introduced by Bertek's NeuroCare(TM) unit, which the company established in July to focus on improving delivery systems and patient compliance for a range of neurological products.

Extended phenytoin, the active ingredient in both Phenytek and Dilantin Kapseals, has been used to treat seizure disorders, especially epilepsy, since its introduction in 1938. "Through patented technology, we have been able to improve upon the delivery and convenience of one of the most trusted and long-standing products for the treatment of epilepsy," said Jim Mauzey, president and chief executive officer of Bertek Pharmaceuticals Inc. "Our new 200 mg and 300 mg extended phenytoin sodium capsules give patients the option of taking their daily dose in one capsule. This unique delivery system may lessen a major problem in motivating non-compliant patients."

Mylan will continue to offer extended phenytoin sodium 100 mg capsules for patients who require more frequent or lower dosages. More than five million prescriptions have been filled with Mylan's extended phenytoin sodium since it was introduced in January 1999.

The most common adverse reactions encountered with phenytoin therapy are associated with the central nervous system and are usually dose related. These include rapid eye movement, loss of muscle control, slurred speech, decreased coordination and mental confusion.

It is estimated that sales of extended phenytoin sodium, both branded and generic, represent a $208 million market in the United States.

Bertek Pharmaceuticals Inc., based in Research Triangle Park, N.C., develops and licenses proprietary pharmaceuticals, with a focus on dermatology, neurology and cardiology. For more information, visit www.bertek.com.

Mylan Laboratories Inc. is a leading pharmaceutical company that develops, manufactures and markets generic and proprietary prescription pharmaceutical products. The Company markets an extensive line of generic products through its three business units, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., and UDL Laboratories, Inc., as well as branded products through its Bertek Pharmaceuticals Inc. subsidiary. For more information, visit www.mylan.com.