Content about Pharmaceutics

NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals has added four new executives, the company said.

Joseph Todisco has been appointed SVP global corporate strategy and business development. Previously serving as VP business development for Ranbaxy, Todisco will be responsible for the growth of Amneal's U.S. generics business and development of partnerships, mergers and acquisitions.

WASHINGTON — Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.

WASHINGTON — The Food and Drug Administration will decide on Wednesday whether to remove merchandising restrictions on the emergency contraceptive Plan B and allow the product to be merchandised in the front-end without age restrictions, according to a report published Monday in the Washington Post.

WHAT IT MEANS AND WHY IT'S IMPORTANT — With annual sales gaining on the $8 billion mark in the United States alone, according to IMS Health, Lipitor (atorvastatin) is the top-selling drug in the world, and the price markdown that Ranbaxy Labs’ launch (and subsequent generic launches) will bring, greatly will expand its accessibility. So it’s no surprise that it has attracted so much media attention over the past few weeks.

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.

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.

TARRYTOWN, N.Y. — Bayer HealthCare and Regeneron Pharmaceuticals have started a late-stage clinical trial in China to evaluate a drug for eye disorders, the companies said Monday.

The drug makers announced the start of the phase-3 "SIGHT" trial of Eylea (aflibercept) injection for the treatment of the neovascular form of age-related macular degeneration, also known as wet AMD. The companies said the trial, which will include about 300 patients, will be the largest retinal trial conducted in China.

NEW YORK — Pfizer is looking to sell its top-selling cholesterol drug directly to consumers at a greatly reduced price after the patent expires, according to published reports.

The Wall Street Journal reported that Pfizer would partner with health plans to sell Lipitor (atorvastatin) directly to consumers through the mail when the drug's patent expires at the end of the month, opening the drug to generic competition.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical has promoted Thomas Haughey to president and Paul Campanelli to COO, the company said. The promotions take effect immediately.

"With the acquisition of Anchen and the pending acquisition of Edict, Par is becoming a larger and more complex organization with three diverse locations and more than 300 additional employees," Par chairman and CEO Patrick LePore said. "These new challenges and opportunities require a president and COO to effectively manage the company and its subsidiaries."

HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon's Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can't be controlled by other drugs.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has completed its acquisition of Anchen Pharmaceuticals, the generic drug maker said.

Par announced plans in August to acquire Irvine, Calif.-based Anchen for $410 million, consisting of a loan and cash it already had.

A privately owned company, Anchen has about 200 employees and more than 72,000 sq. ft. of manufacturing and warehouse space, Par said.