FDA

December 18, 2009 Washington,DC ( RPRN ) 12/18/09 — Please note this is a corrected version of a press release that was posted to FDA's website today. The corrections include a modified headline and a revised second paragraph. The U.S. Food and Drug Administration approved the first generic versions of Aricept (donepezil hydrochloride) orally disintegrating tablet s on Dec. 11. Donepezil hydrochloride is indicated for the treatment of dementia related to Alzheimer’s disease. Orally disintegrating tablets dissolve on the tongue, without having to be swallowed whole. This may make it easier to take the medication for older or disabled patients who have difficulty swallowing. ... Read Full Story

The Food and Drug Administration has approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B. Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDA's accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner. In this case, Novartis demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza. Agriflu is administered as a single injection in the upper arm and is available in single dose, pre-filled syringes that do not ... Read Full Story

Merck & Co. and Santarus Inc. said Tuesday the Food and Drug Administration approved Merck's over-the-counter version of the Santarus prescription heartburn drug Zegerid. San Diego-based Santarus had partnered with Schering-Plough Corp. on the over-the-counter version, and stands to receive a $20 million milestone payment based on the approval. It could also get up to $37.5 million in sales milestone payments, along with royalties on sales. Merck said Zegerid OTC will be available in the first half of 2010. The drug will be sold by the Schering-Plough Health Care Products division, which Merck acquired in November as part of its acquisition of the drug ... Read Full Story

Immunovaccine Inc. said Monday that Pfizer Inc., the world's largest drugmaker, is licensing its technology for use in vaccines for cattle. Terms of the deal between Pfizer Animal Health and Immunovaccine were not disclosed. Immunovaccine, based in Halifax, Nova Scotia, said it will get an upfront payment and milestone and royalty payments on any vaccines developed with the technology by New York-based Pfizer. The company said its vaccines are designed to work with fewer doses than competing drugs and to produce a greater, longer lasting antibody response. In morning trading, Pfizer shares rose 45 cents, or 2.5 percent, to $18.81. Earlier the stock set ... Read Full Story

NEW YORK (Reuters) - Cost cuts helped drugmakers shore up profits in the third quarter, but concerns over sustainable revenue growth continues to worry investors. Merck & Co <MRK.N> earnings easily beat Wall Street expectations on Thursday, while rivals Novartis <NOVN.VX> and Bristol-Myers Squibb Co <BMY.N> posted profits largely in line with projections. But the drug companies posted modest increases in sales and face patent expirations to their biggest products in the next few years, a problem endemic throughout the pharmaceutical industry. "I'd really like to start seeing more solid top line growth -- they've all been rather tepid," said Eldene Doyle, an equities ... Read Full Story