Mylan Pharmaceuticals Inc

Chain Drug Review, Sept 30, 2002

781 Chestnut Ridge Rd.

Morgantown, W.Va. 26505-4310

Phone: (304) 599-2595

(800) 796-9526

Fax: (304) 598-3232

Web site: mylan.com; mylanpharms.com

MORGANTOWN, W.Va. -- Life at 40 is proving to be a busy time for Mylan Pharmaceuticals Inc.

A year after celebrating the completion of its fourth decade in business the generic drug maker has so far had nine new medications approved by the Food and Drug Administration in 2002.

In addition, parent company Mylan Laboratories Inc. recently turned in its best-ever first quarter, entered into a licensing agreement with 3M Pharmaceuticals and began operating under a new senior management team.

The new generic drugs Mylan Pharmaceuticals has been given FDA approval for include nizatidine capsules, tramadol HCl tablets, lisinopril tablets, lisinopril and hydrochlorothiazide tablets, a variety of levothyroxine sodium tablets, buspirone HCl tablets, ketoprofen capsules, metformin HCl tablets and fluoxetine HCl capsules.

The three most recent introductions came within days of one another in July when FDA regulators approved abbreviated new drug applications (ANDAs) for lisinopril tablets, lisinopril hydrochlorothiazide tablets and nizatidine capsules.

The first two of the trio--lisinopril tablets and lisinopril hydrochlorothiazide tablets -- were approved on the same day in early July.

Lisinopril is the generic equivalent of AstraZeneca Pharmaceuticals LP's Zestril tablets and Merck & Co.'s Prinivil tablets, while lisinopril hydrochlorothiazide tablets are a generic version of AstraZeneca's Zestoretic tablets and Merck's prinizide tablets. Both drugs are indicated for the treatment of hypertension, and lisinopril is also used as an adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis and in the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction.

Just days after receiving those approvals Mylan got FDA approval to market nizatidine capsules USP, which is the generic equivalent of Reliant Pharmaceuticals LLC's Axid ulcer treatment.

In June the FDA approved two more of Mylan's ANDAs--one for tramadol HCl tablets, a generic version of R.W. Johnson Pharmaceutical Research Institute's Ultram pain reliever, and one for levothyroxine sodium tablets USP in 11 dosage strengths.

Levothyroxine sodium tablets are the generic equivalent of Jerome Stevens Pharmaceuticals Inc.'s Unithroid tablets for treatment of hypothyroidism and the suppression of thyroid stimulating hormones. They are available in dosages ranging from 0.025 mg. to 0.3 mg.

June also saw Mylan and 3M agree to a deal bywhich Mylan is distributing 50-, 100- and 150-mg. versions of the heart drug flecainide acetate under its own name. 3M markets flecainide acetate tablets under the brand name Tambocor.

Earlier in the year Mylan received FDA approval to market 5-and 10-mg. buspirone HCl tablets, giving it four strengths of the antianxiety drug. The early part of 2002 also saw the company get the OK to market generic ketoprofen capsules and generic versions of Bristol-Myers Squibb's Glucophage (metformin HCl tablets) and Eli Lilly and Co.'s Prozac (fluoxetine HCl capsules).

On the personnel front Mylan Laboratories recently ushered in a new era when it named 41-year-old Robert J. Coury as chief executive officer and 56-year-old Louis DeBone as president and chief operating officer.

"We have long felt it was a priority for Mylan to identify the next generation of leaders for our company," Mylan founder and chairman Milan Puskar comments. "We have been fortunate to find that talent in Robert Coury and Louis DeBone. It is my strong belief that they are the right people to lead Mylan."