Archive for the 'New Drug Approvals' Category

FDA Approves new combination drug to treat diabetes

The FDA as given marketing approval to AstraZenica and Brystol Myers Squibb for their new combination product Kombiglyze XR. Kombiglyze XR is a once daily dose of extended-release metformin and saxaglyptin. Saxaglyptin was previously approved by itself as Onglyza. Saxaglyptin is a member of the new class of anti-diabetic drugs called dipeptidyl peptidase-4 inhibitors, of which Merck’s Januvia/Janumet may be a more familiar member. The drug will compete in the already crowded but important marketplace of oral therapies for type-2 diabetes. Both of the DPP-4 inhibitors and their metformin combinations are top-tier and require prior authorization on popular health plans such as Priority Health and Blue Cross/Blue Shield of Michigan.


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

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: (MYL)

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.

Regular Mail: use postage-paid FDA form 3500 available at: 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.

Prevention of Herpes Zoster – Recommendations of the ACIP

Prevention of Herpes Zoster
Recommendations of the Advisory Committee on Immunization Practices (ACIP)

Thank you to all who attended the September Educational meeting. Below you’ll find links to the Morbidity and Mortality Weekly Report documents cited in tonight’s lecture.

June 6, 2008 / 57(05);1-30 (pdf: 68 pages, 1.4mb)
June 6, 2008 / 57(05);1-30 (html: 68 pages, 164kb)

Sular makes the switch

Sciele, the current manufacturer of the calcium-channel blocker Sular (nisoldipine) has completed the transition to their new tablet formulation and strengths.

UK company SkyePharma’s GeoMatrix technology has been used to develop a new formulation of a hypertension drug which can provide lower drug doses.

The new formulation of Sciele Pharma’s Sular (nisoldipine), a calcium channel blocking agent for the treatment of high blood pressure, has been successfully trialled to show bioequivalence to Sciele’s currently marketed product.

Using SkyePharma’s patented GeoMatrix technology, the new extended release formulation has been designed to provide a lower dose of Sular for each of its current doses, the average dose of which is 10-20mg once a day for adults, and will be more readily absorbed.

Sular’s original form was originally brought to market by Zeneca and used Alza’s OROS osmotic delivery system, which also used in the popular ADHD medication Concerta. Pharmacists will need to contact their patients’ physician to authorize the switch. Equivalency was established by clinical trial as follows:

Generic Sonata Approved

The Food and Drug Administration has approved the following Zaleplon (generic for King’s Sonata) from Roxane, Genpharm, Teva, Sandoz, Upsher Smith, Aurobindo, and Unichem.

Generic Wellbutrin XL 150mg

Teva Introduces Budeprion XL® [Bupropion Hydrochloride Extended-Release Tablets USP (XL)], 150 mg

North Wales, Pennsylvania, May 30, 2008— Teva Pharmaceuticals is pleased to announce the introduction and availability of Budeprion XL® [Bupropion Hydrochloride Extended-Release Tablets USP (XL)], 150 mg. This product is AB rated and bioequivalent to Wellbutrin XL®* Tablets. With the addition of this new strength, Teva now offers Budeprion XL® Tablets in 150 mg and 300 mg strengths, in bottle sizes of 30 and 500.

New Approvals for Late May

The FDA has approved the following products:

  • GlaxoSmithKline’s Entereg:

    Entereg (alvimopan) is a peripherally-acting mu opioid receptor (PAM-OR) antagonist designed to block the adverse side effects of opioid analgesics on the GI tract without blocking their beneficial analgesic effects.

  • Tentative approval for Teva’s Lansoprazole, the generic equivalent of Prevacid.
  • Tentative approval for both Cobalt Labs and Ivax’s Topiramate, the generic equivalent of Topamax.
  • Tentative approval for Apotex’s Escitalopram oxalate, the generic equivalent of Lexapro.

April/May NDAs

The FDA has approved the following drugs in April and May:

  • Taclonex Scalp Suspension (calcipotriene; betamethasone diproprionate) details
  • A variety of cetirizine products from various vendors continues to enter the marketplace.
  • Patanase nasal spray (olapatadine) detail
  • Treximet (sumatriptan/naproxen sodium) detail
  • Aplenzin (buproprion hydrobromide) detail

Generic Requip

Teva Introduces Ropinirole Hydrochloride Tablets
North Wales, Pennsylvania, May 7, 2008 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Ropinirole Hydrochloride Tablets. This product is AB rated and bioequivalent to Requip®* Tablets. Ropinirole HCl Tablets are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths, in bottle sizes of 100.

“Generic pharmaceuticals are playing an increasingly important role in healthcare cost containment,” states John Denman, V.P. Sales and Marketing. “Teva Pharmaceuticals continues to lead the way with timely new product launches.”

Teva Pharmaceuticals, located in North Wales, Pennsylvania, is the leading pharmaceutical manufacturer for both new and total prescriptions.‡ The company has an aggressive Research and Development effort and one of the best overall ANDA approval records in the industry.‡

* Requip® is a registered trademark of SmithKline Beecham P.L.C.
‡ Data on file, Teva USA.