FDA approves KV’s generic Toprol
ST. LOUIS KV Pharmaceuticals has received final approval from the Food and Drug Administration for its generic version of AstraZeneca’s hypertension drug Toprol XL 50 mg.
The company is now offering all milligrams of metoprolol succinate extended-release tablets: 200 mg, 100 mg, 50 mg and 25 mg.
The brand and generic versions of the 50 mg strength had sales in 2007 of $585 million according to IMS America.
Chinese companies set to enter generic market
LONDON Chinese drug manufacturing companies are now looking to get into manufacturing generic drugs, according to Reuters. The country is already the world’s biggest producer of active pharmaceutical ingredients and is now aiming at producing finished drug products for sale in the U.S., Europe and other key markets.
IMS Health said last year’s first approval from the Food and Drug Administration for a Chinese generic—a copy of AIDS drug nevirapine—was a sign of things to come. Now, at least 10 other Chinese companies are set to follow suit with other generic products, according to IMS.
The result will be increased competition in a generic drugs industry that is already struggling with tumbling prices. The rise of Chinese generic drugmakers is expected to mirror that of Indian firms like Ranbaxy Laboratories, which also started out as an API supplier but moved into finished generic medicines a decade ago.
The problem, though, according to IMS, is safety issues involving the drugs. The most noticeable problem, the tainted blood thinner heparin that was produced in China and then created a health scare across the globe.
Pfizer supports transparency initiative by listing Q1 grants
NEW YORK Following in line of such other pharmaceutical companies as Eli Lilly, Pfizer has begun listing its U.S. medical, scientific and patient organization grants and charitable contributions made in the first quarter of 2008, as part of a mission to increase company transparency.
Of a total $9.97 million in grants and charitable contributions reported for the first quarter of 2008, the largest grant, $3,420,318, was made to the California Academy of Family Physicians in March for a three-year national health care professional education campaign to reduce the number of U.S. smokers. This grant was distributed among nine partner organizations across the country.
Other grants include $500,000 to Family Health International for malaria patient education and treatment, and $237,500 to the Massachusetts Institute of Technology for its clinical investigator training program with Beth Israel Deaconess Medical Center.
“We want to bring greater transparency to the way we partner with leading medical, scientific and patient organizations,” said Jeffrey Kindler, chairman and chief executive officer of Pfizer. “Detailing these grants and charitable contributions is an important part of our ongoing transparency drive.”
The company plans on updating its information each quarter.