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The FDA should move forward and approve generic versions of McNeil Consumer & Specialty Pharmaceuticals’ attention deficit/hyperactivity disorder drug Concerta, argues a law firm in response to a McNeil citizen petition that has delayed generic entry.
Brand firm Johnson & Johnson (J&J) says authorized generics are legal under FDA regulations and any move to keep them off the market until another generic firm’s 180-day exclusivity period expires would violate federal drug law.
Unless the pharmaceutical industry takes steps to reduce the global price disparity for prescription drugs — including cutting prices in the U.S. — the importation of Rx drugs and price controls are inevitable, according to a new report from Ernst & Young.
The expected launch date of Pfizer’s new prostate gland drug Cardura XL (doxazosin mesylate), which will be distributed by generic firm Andrx, has been pushed back, according to a pharmaceutical analyst who lowered expected revenues on the brand product.
Several generic firms last week launched versions of Bristol-Myers Squibb’s (BMS’) Type 2 diabetes drug Glucophage XR, 500-mg strength tablets, under a “second tier” of 180-day marketing exclusivity.
GlaxoSmithKline (GSK) will post the results of its clinical trials on the internet, the firm said Friday, less than three weeks after it was sued in New York for allegedly concealing negative data about its antidepressant Paxil.
Generic firms can develop generic biologics using available raw materials, and the FDA can approve the products as fully substitutable for their brand equivalents under current regulations, according to Barr Pharmaceuticals’ executives, who challenged some commonly held perceptions about the complex molecules.