FDA okays marketing generic form of Valium - C&EN Global

Nov 7, 2010 - The popular tranquilizer Valium will soon be available in its generic form, diazepam. Approved last week by the Food & Drug Administrati...
2 downloads 12 Views 130KB Size
leveraged buyout combination, analysts believe it will be difficult for them to refuse Hanson's offer if Merrill Lynch quits the field. At any rate, Hanson was cleared by federal antitrust officials last week to begin buying shares under its sweetened offer. In reaction, SCM announced that if the leveraged buyout bid was not boosted to equal Hanson's offer by early this week, the deal with Merrill Lynch would be canceled. The bidding war began Aug. 21, when Hanson offered $60 per share for SCM, which manufactures chemicals, coatings and resins, paper products, food products, and typewriters. SCM management rejected that unsolicited offer as inadequate. It is thought that if Hanson acquires the U.S. firm, SCM chairman Paul H. Elicker and president D. George Harris will leave the company, opening "golden parachutes" as they go. In addition, an acquisition by Hanson would mean that SCM would pay Merrill Lynch $10.5 million in agreed fees. D

FDA okays marketing generic form of Valium The popular tranquilizer Valium will soon be available in its generic form, diazepam. Approved last week by the Food & Drug Administration, diazepam products will have the same bioavailability and therapeutic effect as the brandname drug. Valium is the fourth-largest-selling prescription drug in the U.S. The approval of diazepam was made possible by the 1984 Drug Price Competition & Patent Term Restoration Act. One section of that law drops old patent protections on some drugs, making it easier for manufacturers to produce generic versions. Previously, any drug patented after 1962 had special protections and could not be produced generically. Under the 1984 law, once a company has applied for approval of a generic product, FDA must respond to that application within 180 days. The patent on diazepam expired in February. Health & Human Services Secretary Margaret M. Heckler, in an-

nouncing the approval of diazepam products, emphasized that diazepam is only one of seven important generic drugs approved this year. She says the use of these products is expected to decrease the costs of prescriptions 30 to 40%. According to HHS estimates, Valium sales amounted to $354 million in 1984, and a spokesman for FDA guessed prices for diazepam could run 25% lower than Valium, a savings of nearly $90 million if all prices were the same. Approval of diazepam is somewhat controversial. The drug's creator and patent holder since 1963 is Hoffmann-La Roche, Nutley, N.J. The company claims that early generic versions of the drug were inferior to Valium and that FDA should not approve those products. There is also some concern that the bioavailability tests FDA uses are not modern enough to yield good data. The head of FDA's generic review office, Marvin Seife, refutes this, saying that FDA's procedures are state-of-the-art and that the approved products are not the same as those that ran into problems earlier. Hoffmann-La Roche is making no prediction as to how the generic product approval will affect Valium sales. The three companies licensed to sell diazepam products are Mylan Pharmaceuticals of Morgantown, W.Va., Parke-Davis division of

Heckler: 30 to 40% cut in costs

Warner Lambert of Morris Plains, N.J., and Zenith Laboratories of Northvale, N.J. Heckler says that, with approval of generic versions of Valium, nine of the 10 top prescription drugs in the U.S. are available in generic form or have less costly alternatives. The exception is the ulcer treatment drug Tagamet. G

EPA boosts list of Superfund sites to 850 The Environmental Protection Agency again has updated its list of Superfund sites, proposing 38 new hazardous waste sites and bringing the total number of proposed or final sites on its National Priorities List to 850. Only sites listed on the NPL are eligible for remedial cleanup funds under the Superfund program. Eighteen states have sites listed in this latest update. And for once, New Jersey doesn't lead with the most proposed sites. That honor is shared jointly by Iowa and Pennsylvania, with five sites each. EPA plans to place all 38 proposed sites on the final NPL this year. In this latest update, EPA's fourth, nine Resource Conservation & Recovery Act-related sites are proposed for long-term cleanup. The agency, however, is struggling with its current policy of listing such sites and making them eligible for cleanup under Superfund. EPA may defer such action until it has exhausted all corrective measures under RCRA. Although federal facilities are not eligible for cleanup funds under Superfund because the law's implementing regulation, the National Contingency Plan, prohibits it, EPA has chosen to propose such facilities for the NPL. In this update, EPA has proposed three Navy facilities, bringing the total number of proposed federal facilities to 39. No action will be taken on these until EPA decides on appropriate changes to the National Contingency Plan. EPA also has included the Silver Creek Tailings mining site in Park City, Utah. No permanent cleanup will proceed at Silver Creek or any other mining site on the NPL until EPA and the Department of Interior resolve jurisdictional issues. September 9, 1985 C&EN

5