FDA approves generic epilepsy treatment
PITTSBURGH Generic drug maker Mylan has received the Food and Drug Administration’s approval for its version of a drug used to treat epilepsy.
Mylan announced Thursday the approval of its topiramate sprinkle capsules in the 15-mg and 25-mg strengths. The capsules are designed to be opened and sprinkled onto soft food and are a generic version of Johnson & Johnson’s Topamax Sprinkle Capsules.
The branded version of the drug had sales of $58 million for the 12-month period ended June 30, according to IMS Health data.
Abbott reports Q3 results
ABBOTT PARK, Ill. Drug maker Abbott reported strong sales in its third-quarter 2009 earnings report Wednesday.
The company reported an increase of 8.4% in global sales, which remained at 3.5% when factoring in the rise in the value of the dollar. Excluding the dollar’s rise, pharmaceutical sales were 3.9%, but dipped into the red, to -1.6%, when including foreign exchange rates. Nutritional and medical products had much stronger sales – 11.1% and 9.8%, respectively – when the dollar’s value was included.
“Abbott is performing well, generating higher-than-expected earnings growth in the fourth quarter,” Abbott chairman and CEO Miles White said in a statement. “During the quarter, we announced several acquisitions that support our long-term growth strategy. These acquisitions add to our diverse mix of global businesses, with new technologies, established products and emerging market infrastructure that will help us deliver sustainable industry-leading growth.”
Mylan, Pfizer settle drug dispute
PITTSBURGH Generic drug manufacturer Mylan and pharmaceutical giant Pfizer have settled a dispute over Mylan’s attempt to manufacture a generic version of an antifungal drug.
Mylan announced Wednesday that it had entered a license agreement with Pfizer concerning Mylan subsidiary Matrix Labs’ voriconazole tablets in the 50-mg and 200-mg strengths, a generic version of Pfizer’s Vfend. Matrix had filed a regulatory approval application with the Food and Drug Administration; as the first company to file the application, Mylan will have the right to market its version in direct competition with Pfizer’s product for six months once the patent expires. Under the agreement, Mylan will have the right to market voriconazole tablets in the U.S. in first quarter 2011.
Vfend, used to treat yeast and other fungal infections, had sales of $164 million during the 12-month period ending June 30, according to IMS Health data.