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Archive for June, 2010

Generic Arimidex On the Way

Tuesday, June 29th, 2010

Today Mylan announced that they had received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Anastrozole tablets, 1 mg, the generic version of AstraZeneca’s Arimidex, a treatment for early breast cancer.

According to IMS Health, Anastrozole tablets had sales in the US of approximately $917 million for the last year ending March 31, 2010 . The product is available for immediate shipment.

Pr Newswire Reported that,

Currently, Mylan has 136 ANDAs pending FDA approval representing $94 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $20.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 according to IMS Health.

This should help those who are struggling to pay for the treatment. If you would like to save even more on Arimidex, join No Prescription Needed today!

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Glaxo Increases OTC Medicines With New Cold Sore Cream

Wednesday, June 23rd, 2010

GlaxoSmithKline  and Medivir announced today an exclusive agreement for the commercialization of a new over the counter cold sore cream. Xerclear is the new product that will contain acyclovir and hydrocortisone for non-prescription use in multiple markets, including 14 major European countries.

This should bolster Glaxo’s over the counter medicine business. According to reports,

Swedish-based Medivir will get up to 3 million euros ($4 million) in upfront and pre-launch milestone payments, as well as up to double-digit percentage royalties on sales.

The new combo was granted marketing approval in  in last October and is based on strong clinical data. Xerclear was given “a unique label, which differentiates it from other topical cold sore products currently on the market,” GSK says.

According to the Pharma Times,

The treatment, previously known as Lipsovir, will be distributed as part of GSK’s over-the-counter Zovirax (acyclovir) franchise in multiple markets, including Europe, Russia, Japan, India, Australia and New Zealand but not North and South America, China, South Korea and Israel. The drugs giant will pay up to 3 million euros in upfront and pre-launch milestones and up to double-digit royalties.

Only time will tell if Xerclear will ever make it to market in the US.

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New Drug Approved to Fight Osteoporosis

Tuesday, June 1st, 2010

osteoporosis medication 225x300 New Drug Approved to Fight Osteoporosis

Today a new drug was approved for sale to fight against osteoporosis. The new drug Prolia comes from Amgen and is used to help prevent fractures in postmenopausal women. Last week, the medicine received approval for sales overseas.

Prolia is considered to be one of the most important drugs for Amgen’s future. The FDA’s decision was made nearly two months before the agency’s expected date, July 25.

Dr. Julie Beitz, director of an F.D.A. office of drug evaluation, said in a statement “Due to its prevalence, osteoporosis is a serious concern to public health…the approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.”

This is good news for the rising number of postmenopausal women who recent studies have shown that one out of every two women over age 50 will break a bone in their lifetime as a result of osteoporosis.

Prolia will join other osteoporosis medications such as Fosamax and Boniva to help fight against bone loss in women over 50.

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