Generic Product News and Generic News

Published Online: Tuesday, July 13, 2010


Metaxalone Tablets

Marketed by:
Sandoz Inc (Princeton, NJ)

Compared to:
Skelaxin (King Pharmaceuticals Inc)

Indication:
Sandoz Inc announced the launch in the United States of the first generic version of metaxalone tablets, a generic equivalent of King Pharmaceuticals Inc’s Skelaxin. As the first generic version brought to market, Sandoz will have a 180-day abbreviated new drug application exclusivity. Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions.

Dosage:
Tablets: 800 mg

For More Information:
www.us.sandoz.com








Imipramine Pamoate Capsules

Marketed by:

Roxane Laboratories Inc (Columbus, OH)

Compared to:
TOFRANIL-PM (Covidien)

Indication:
Roxane Laboratories Inc announced the FDA approval of its abbreviated new drug application for Imipramine Pamoate Capsules, 75, 100, 125, and 150 mg. Roxane Laboratories’ Imipramine Pamoate Capsules are AB-rated to TOFRANIL-PM capsules. The product is indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to 3 weeks of treatment may be needed before optimal therapeutic effects are evident.

Dosage Form:
Capsules: 75, 100, 125, and 150 mg

For More Information:
www.Roxane.com
800-962-8364



Valacyclovir Hydrochloride Tablets

Marketed by:

Teva Pharmaceuticals (North Wales, PA)

Compared to:
Valtrex (GlaxoSmithKline LLC)

Indication:
Teva Pharmaceuticals announced the availability of Valacyclovir Hydrochloride Tablets. This product is AB-rated and bioequivalent to Valtrex Caplets. Valacyclovir Hydrochloride Tablets are a nucleoside analogue DNA polymerase inhibitor indicated for cold sores (herpes labialis), genital herpes, and herpes zoster in adult patients, as well as cold sores (herpes labialis) in pediatric patients. The tablets are available in 500- and 1000-mg strengths, in bottle sizes of 30 and 90.

Dosage:
Tablets: 500 and 1000 mg

For More Information:
www.tevausa.com
888-TEVA USA (888-838-2872)




Simvastatin Tablets USP

Marketed by:

Mylan Pharmaceuticals Inc (Morgantown, WV), a subsidiary of Mylan Inc (Canonsburg, PA)

Compared to:
Zocor (Merck & Co Inc)

Indication:
Mylan Inc recently announced that its subsidiary, Matrix Laboratories Ltd, received final approval from the FDA for its abbreviated new drug application for Simvastatin Tablets USP, 5, 10, 20, 40, and 80 mg, the generic version of Merck & Co’s Zocor Tablets, a treatment for high cholesterol. The product will be distributed by Mylan Pharmaceuticals Inc.

Dosage Form:
Tablets: 5, 10, 20, 40, and 80 mg

For More Information:
www.mylan.com




Heparin Sodium Injection, USP

Marketed by:

Sagent Pharmaceuticals Inc (Schaumburg, IL)

Indication:
Sagent Pharmaceuticals Inc announced that the FDA approved the company’s 9 presentations of heparin sodium injection, USP. Heparin is a vital anticoagulant, routinely used in surgical and dialysis settings, which prevents the formation of clots and extension of existing clots within the blood. The heparin is latex-free and features the company’s proprietary PreventIV Measures packaging and labeling, which aids users in distinguishing between the 9 presentations. Sagent’s packaging and labeling features for heparin include the use of a unique color for each total strength; easy-to-read drug name, concentration, and fill volume; and cartons printed on all sides.

Dosage Form:
Glass vials containing: 1000 USP units per mL; 2000 USP units per 2 mL; 10,000 USP units per 10 mL; 30,000 USP units per 30 mL; 5000 USP units per mL; 50,000 USP units per 10 mL; 10,000 USP units per mL; 40,000 USP units per 4 mL; 20,000 USP units per mL

For More Information:
www.sagentpharma.com




Azelastine Ophthalmic Solution, 0.05%

Marketed by:

Caraco Pharmaceutical Laboratories, Ltd (Detroit, MI)

Compared to:
Optivar Ophthalmic Solution, 0.05% (Meda Pharmaceuticals)

Indication:
Caraco Pharmaceutical Laboratories, Ltd began shipping azelastine ophthalmic solution, 0.05%. This product was recently approved by the FDA for Sun Pharma’s abbreviated new drug application. This sterile azelastine hydrochloride ophthalmic solution is therapeutically equivalent to Optivar Ophthalmic Solution, 0.05%. Azelastine ophthalmic solution is indicated for the treatment of itching of the eyes associated with allergic conjunctivitis.

Dosage Form:
The recommended dose is 1 drop instilled into each affected eye twice a day.

For More Information:
www.caraco.com


Generic News
 
State Policy Can Influence Generic Substitution, Reduce Medicaid Costs

A policy change could save states more than $100 million in prescription drug costs, according to a study published in the July issue of Health Affairs. By adopting laws that encourage the use of generic drugs by Medicaid beneficiaries, states can reduce the increasing costs of caring for this population.

Current laws in several states require patient consent before a chemically equivalent generic medication can be substituted for a brand drug. Designed to increase patient autonomy, this policy also incurs “sizable opportunity costs,” the researchers reported.

“Requiring patients to provide consent prior to generic substitution led to an approximately 25% reduction in generic substitution,” said lead author William H. Shrank, MD, MSHS, assistant professor of medicine in the Division of Pharmacoepidemiology at Harvard Medical School’s Brigham and Women’s Hospital.

A more cost-effective policy would allow pharmacists to make the switch as soon as a brand medication’s patent expires. With patents for Lipitor, Plavix, and Zyprexa set to expire within the next 2 years, the savings of such a policy could add up to more than $100 million, Dr. Shrank and his colleagues estimated.

GPhA Conference to Highlight FDA Regulatory Issues
More than 500 generic industry professionals and FDA representatives will converge in North Bethesda, Maryland, this year for the Generic Pharmaceutical Association’s (GPhA) 2010 Fall Technical Conference, to be held October 19 to 21.

The conference was created to help the generic industry stay abreast of developments within the FDA and will feature keynote speaker Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

Presentations by top FDA officials will focus on regulatory and technical issues facing the generics industry, including bioequivalence and supply chain security, among other topics. A preconference workshop is also planned, in which attendees will participate in a question-and-answer session with project managers from the FDA’s Office of Generic Drugs.

In addition to scheduled educational programming, a series of luncheons and other informal gatherings throughout the conference will provide numerous opportunities for networking and information gathering. For more information or to register, visit www.gphaonline.org/events.


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