Medicis calls on FDA to amend draft guidance
SCOTTSDALE, Ariz. Medicis is arguing in a citizen’s petition aimed at the Food and Drug Administration that a waiver provision in its draft guidance of bioequivalence requirements would put the public at risk.
The company is directly referring to its acne drug Solodyn. Medicis doesn’t want the FDA to approve any generic version of the drug without bioequivalence testing for each strength of the drug.
As of now, the draft guidelines only require testing for the highest strength of the drug, 135 mg, and gives a waiver to the 45 and 90 mg strengths as long as they are “proportionally similar” to the 135 mg tablet.
But, according to Medicis’ March 20 petition, the 45 and 90 mg strengths of Solodyn are not dose-proportional to the 135 mg strength. The company had believed the various strengths to be proportional, but newer bioequivalence data has shown otherwise, it says. Therefore, it also is asking the FDA to designate the 90 mg Solodyn as a separate reference-listed drug from the 135-mg strength.
Rite Aid posts sales increase for March
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.
FDA grants orphan designation for MELAS syndrome drug
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.