Generics

ATLANTA — As many as 111 million Americans had gotten a flu shot by mid-November, representing 36% of the 305 million Americans over the age of 6 months, the Centers for Disease Control and Prevention stated in a media telebriefing Monday afternoon. The number of people getting vaccinated is up slightly from last year, the CDC reported, most notably among children and seniors.

AMITYVILLE, N.Y. — Net sales for Hi-Tech Pharmacal rose 27% for its second quarter ended Oct. 31, the drug maker said.

PITTSBURGH — Under the President's Emergency Plan for AIDS Relief, the Food and Drug Administration has given tentative approval to a generic HIV and AIDS drug made by Mylan, the company said.

The drug maker's Mylan Labs subsidiary received tentative approval for atazanavir sulfate and ritonavir tablets in the 300-mg/100-mg strength. The FDA's tentative approval of the drug under PEPFAR means it will be eligible for purchase in certain developing countries.

TRENTON, N.J. — Six retailers on Wednesday filed suit naming Wyeth and Teva Pharmaceuticals as defendants and alleging that the defendants unlawfully delayed the entry of generic versions of Wyeth's antidepressant Effexor XR (venlafaxine). A summons was issued to Wyeth and Teva on Thursday.

The retailers include Ahold USA, H-E-B, Kroger, Safeway, Supervalu and Walgreens. The companies are suing for three-times damages plus attorneys fees.

Wyeth was acquired by Pfizer in October 2009.

SILVER SPRING, Md. — Ranbaxy Labs got the green light from the Food and Drug Administration Wednesday night to launch its generic version of Pfizer's cholesterol-lowering drug Lipitor.

The FDA announced the approval of Ranbaxy's atorvastatin calcium tablets in the 10-mg, 20-mg, 40-mg and 80-mg strengths. New Brunswick, N.J.-based Ohm Labs will manufacture the drug.

PITTSBURGH — Mylan said its subsidiary has launched a generic version of a hypertension treatment.

The company said Mylan Pharmaceuticals launched and begun shipping amlodipine besylate and atorvastatin calcium tablets in the 2.5-mg/10-mg; 2.5-mg/20-mg; 2.5-mg/40-mg; 5-mg/10-mg; 5-mg/20-mg; 5-mg/40-mg; 5-mg/80-mg; 10-mg/10-mg; 10-mg/20-mg; 10-mg/40-mg and 10-mg/80-mg strengths. The drug is a generic version of Pfizer's Caduet.

Caduet tablets had U.S. sales of approximately $339 million for the 12 months ended Sept. 30, according to IMS Health.

NEW YORK — Pfizer's efforts to protect the sales of its blockbuster cholesterol drug Lipitor have attracted scrutiny from members of Congress, according to published reports.

The New York Times reported Thursday that three senators — Max Baucus, D-Mont.; Chuck Grassley, R-Iowa; and Herb Kohl, D-Wis. — had asked Pfizer and five other companies to provide details of their agreements to prevent dispensing of generic versions of Lipitor (atorvastatin) and dispense only the branded version.

PITTSBURGH — Generic drug maker Mylan and a partnering company are challenging the patent on a contraceptive drug.

Mylan said Thursday that it and Famy Care had been sued by Warner Chilcott in the U.S. District Court for the District of New Jersey following their filing of a regulatory approval application with the Food and Drug Administration for norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets, a generic version of Warner Chilcott's Generess Fe.