Caraco receives tentative FDA approval for generic Lamictal
DETROIT Caraco Pharmaceuticals has received tentative approval from the Food and Drug Administration for its application for lamotrigine tablets, the generic version for the anti-seizure and bipolar disorder medication Lamictal.
The company expects final approval before the patent expiration of the brand, which is scheduled for Jan. 22, 2009. The drug will be available in all forms of the brand, which include: 25 mg, 100 mg, 150 mg and 250 mg.
“We are extremely pleased to receive this tentative approval and look forward to the expiration date of the patent in January 2009, which will allow Caraco to market the product.” Daniel Movens, Caraco’s chief executive officer, said. “We feel that generic Lamictal will be a positive addition to our portfolio by expanding our product offerings.”
According to IMS data, the drug had sales in the U.S. of about $1.89 billion for the year ended Sept. 30, 2007.
Rite Aid announces program to help seniors with Medicare Part D
CAMP HILL, Pa. With the 2008 Medicare Part D Prescription Drug Plan open enrollment period beginning Nov. 15, Rite Aid on Monday announced that their pharmacies will look to playing a key role in educating seniors so they can make informed decisions about the best plan choice for their prescription needs.
“Rite Aid is committed to making sure our senior patients are fully educated and understand the Medicare prescription drug benefit,” stated Mark de Bruin, Rite Aid’s executive vice president of pharmacy. “We’ve teamed up with leaders in the managed care industry to create user friendly, detailed information on the Medicare Part D benefits as well as helpful step by step tips to help them determine the best Medicare Part D plan for their prescription needs. In addition, our 14,000 Rite Aid pharmacists are available to answer questions and offer explanation on the intricacies of the Medicare Part D prescription drug benefit.”
All Rite Aid pharmacies are offering a free detailed Medicare Prescription Drug Plan Guide. In addition, Rite Aid pharmacists are trained on Medicare Part D to help seniors and caregivers navigate through the numerous plan options. Rite Aid also has a special website, www.riteaid.com/medicareadvisor, which allows patients to compare drug prices and get a complete list of plan options offered in their local area. Some Plans include a link to online enrollment forms.
To help educate its pharmacy patients 65 years and older on the various Medicare Part D Prescription Drug Plan options, Rite Aid has partnered with AARP/United Healthcare, Aetna and Wellpoint to provide detailed and useful in-store educational materials.
FDA committee to examine new indication for Avastin
WASHINGTON The FDA’s Oncologic Drugs Advisory Committee is set to review Genentech’s cancer drug, according to reports.
The advisory committee, which will meet Dec. 5, is said to discuss a new indication for Genentech’s cancer drug Avastin.
Genentech has experienced some backlash from wholesalers and pharmacies over the drug, which is chemically similar to the company’s drug Lucentis, used to treat macular degeneration, a severe eye condition that usually occurs at a later age.
Although Avastin is not approved for ophthalmologic use, physicians use it instead of Genentech’s chemically similar drug Lucentis (ranibizumab), which is considerably more expensive.
Chairman for the Senate Special Committee on Aging, Herb Kohl, D-Wis., opposed the company’s new policy, saying it would cost taxpayers billions of dollars through higher Medicare costs.
Genentech said it would delay implementing its new distribution policy until Jan. 1, 2008.
In the first six months of this year, Avastin had sales of $1.1 billion and Lucentis had sales of $420 million.