PHARMACY

FDA approves GSK’s Rotarix

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved GlaxoSmithKline’s rotavirus prevention vaccine Rotarix. This is the second oral vaccine to be approved after Merck’s RotaTeq.

Rotavirus is an infection that causes gastroenteritis in infants and children and affects almost 3 million children each year.

Rotarix is a liquid and given in a two-dose series to infants from six to 24 weeks of age. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4 and G9 strains.

During studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of rotavirus-caused gastroenteritis during the first two years of life. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.

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Rite Aid posts sales increase for March

BY Michael Johnsen

CAMP HILL, Pa. Rite Aid on Thursday reported a same-store sales increase of 2.6 percent (which does not yet include the Brooks/Eckerd acquired stores) for the four weeks ended March 29.

Pharmacy same-store sales increased 1 percent, which included an approximate 493 basis points negative impact from new generic introductions. Front-end same-store sales were up 5.7 percent. March same store sales were positively affected by a shift to a March Easter this year from an April Easter last year (March 23 this year as compared to April 8 last year).

Total drug store sales for the four-week period increased 50.7 percent to $2 billion. Prescription revenue accounted for 67.6 percent of drugstore sales, and third party prescription revenue represented 96.2 percent of pharmacy sales.

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FDA grants orphan designation for MELAS syndrome drug

BY Diana Alickaj

WASHINGTON Sirtris Pharmaceuticals has been granted orphan drug designation for resveratrol by the Food and Drug Administration, according to published reports.

Resveratrol is a drug used to treat MELAS syndrome, a progressive fatal aging disease that produces symptoms of muscle weakness, fatigue, recurrent headaches and seizures. The government’s grant is usually offered in cases in which companies are discovering treatments for rare drugs, and the grant would allow the company to speed up their testing period.

Sitris has decided to focus on the SIRT1 gene, which is a gene tied to the aging process. SIRT1 is being studied as a possible source in treating MELAS or type 2 diabetes. According to published reports, the grant has resulted in Sitris being offered seven years of marketing exclusivity for its formulation of resveratrol.

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