Generics of Valeant’s Efudex delayed by FDA until end of month
ALISO VIEJO, Calif. Valeant Pharmaceuticals was informed by the Food and Drug Administration that the agency has entered an administrative order “in the public interest” to delay the approval of a generic version of its drug Efudex cream 5 percent until May 30.
The FDA is taking this extra time, “because there are outstanding questions regarding this approval that it must consider.” The agency originally approved the generic form of the drug, fluorouracil cream 5 percent, back on April 11 for Spear Pharmaceuticals.
On the same day, the FDA responded to Valeant’s Dec. 21, 2004, Citizen Petition regarding potential generic versions of Efudex cream 5 percent. In the Citizen Petition, Valeant requested that the FDA decline to approve generic versions of the drug where the generic company has failed to provide test data comparing the generic product to Efudex Cream in patients diagnosed with superficial basal cell carcinoma, a form of skin cancer.
The drug is approved for the treatment of multiple actinic or solar keratoses, and for the treatment of superficial basal cell carcinomas when conventional methods of treatment are impractical.
The agency hopes to have the matter resolved by May 30 and Spear has agreed to halt production and launch of the generic until that date.
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.