Monthly Archive for November, 2008

Lost bag.

Maria Szatkowski has lost a product bag at the last Friday night meeting. It has some product in it that she has to inventory. If you got the bag by accident could you please phone her at (269)598-8563.

Ivax receives approval for generic Pulmicort Respules

Ivax (now owned by Teva Pharmaceuticals) have received FDA approval to market their generic version of AstraZeneca’s Pulmicort Respules in 0.25mg/ml and 0.5mg/ml strengths. More details here.

Mylan Receives Tentative FDA Approval for the Generic Version of the Antidepressant Effexor XR

PITTSBURGH, Nov. 17 /PRNewswire-FirstCall/ — Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Extended-release (ER) Capsules, 37.5 mg (base), 75 mg (base) and 150 mg (base).

Venlafaxine HCl ER Capsules, indicated for the treatment of major depressive disorder and generalized anxiety disorder, are the generic version of Wyeth Pharmaceutical Inc.’s Effexor XR(R) Capsules. This product had annual U.S. sales of approximately $3 billion for the 12 months ending Sept. 30, 2008, for the noted strengths, according to IMS Health.

Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry’s broadest — and highest quality — product portfolios, supported by a robust product pipeline; owns a controlling interest in the world’s third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.

SOURCE Mylan Inc. 11/17/2008 CONTACT: Media: Michael Laffin, +1-724-514-1968, or Investors: Dan Crookshank, +1-724-514-1813, both of Mylan Inc. /Web site: http://www.mylan.com (MYL)

SWMPA DINNER

Osteoporosis Therapy Updates
Formulary Updates
Trivia & Prizes!

Friday, November 21, 2008
6:30PM Refreshments
7:00PM Hors d’oeuvres and Party
Limited to the first 30 reservations due to limited seating.
If you are attending Thursday’s dinner, please consider others who might instead be able to attend tonight.

RSVP to William Urfer (269)381-2256 or william@swmpa.org by November 17.

Or use Google Calendar

CEU Pending.

Food Dance Cafe
401 E Michigan
Kalamazoo, MI 49007

View Larger Map

Graciously sponsored by Maria Szatkowski of Sanofi-Aventis

FDA Approves Toviaz, a New Drug to Treat Overactive Bladder

The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB.

“Patients who suffer from overactive bladder face quality of life issues that can hamper their ability to enjoy life to its fullest,” said George Benson, M.D., deputy director, Division of Reproductive and Urologic Products at the FDA’s Center for Drug Evaluation and Research. “This new drug will provide an additional treatment option to help them manage problems with an overactive bladder.”

Toviaz will be available by prescription only, as an extended release tablet in either 4 mg or 8 mg dosage strengths. It is to be administered once daily. The recommended starting dose is 4 mg, which can be increased to 8 mg if needed, based upon individual response and tolerability. Toviaz is only approved for adults.

The safety and effectiveness of Toviaz were studied in two, 12-week, randomized controlled studies of the 4 mg and 8 mg doses. For the combined studies, a total of 554 patients received placebo, 554 patients received Toviaz 4 mg daily, and 566 patients received the drug 8 mg daily. The majority of patients were female with a mean age of 58 years. Toviaz is not approved for pediatric use.

In each of those two studies, the product showed a statistically significant and clinically meaningful improvement in decreasing the number of times patients needed to urinate per day, as well as the number of urine leaking episodes they experienced per day, as compared to placebo.

Common side effects associated with Toviaz included dry mouth and constipation. Less frequently reported side effects included dry eyes and trouble emptying the bladder.

Toviaz is not recommended in doses above 4 mg in those patients with severe reduction in kidney function or in those patients taking medications, such as ketoconazole, that block the metabolism of the drug. It should not be used in patients who suffer from urinary or gastric retention or in patients with uncontrolled, narrow-angle glaucoma. It should also not be used in patients with severe liver impairment. The product should be used with caution in patients who suffer from decreased gastrointestinal motility, such as those with severe constipation.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch,
5600 Fishers Lane, Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088

Toviaz is manufactured by Schwarz Pharma of Zwickau, Germany and is distributed by Pfizer Inc. of New York, N.Y.