House passes PDUFA bill 387 to 5
WASHINGTON — The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.
The bill, a version of which already passed through the Senate, now heads to committee where the House and Senate versions of the bill can be reconciled before Oct. 1 and submitted to the president. According to published reports, the Senate version would require more scrutiny for some new devices.
The House’s FDA Reform Act of 2012 (H.R. 5651) includes reforms to the FDA’s current evaluation and approval processes for prescription drugs and medical devices that makes the process more efficient, transparent and consistent, noted bill sponsor Fred Upton, R-Mich. Under current law, U.S. companies have been put at a competitive disadvantage with overseas manufacturers, who already benefit from a more streamlined approval process, Upton noted in a statement released Wednesday.
Upton expected a final bill to reach the president’s desk by early summer.
H.R. 5651 reauthorizes for five years the Prescription Drug User Fee Act and the Medical Device User Fee Act. Under these user fee agreements, the FDA collects fees directly from medical manufacturers to fund the agency’s drug and device approval processes. The legislation also establishes new user fee programs for generic drugs and biosimilars, and encourages the development of treatment options for children with rare diseases.
Lawmakers must reconcile differences in the bills, such as dates for the FDA to comply with certain provisions and language in the Senate’s version that would require more scrutiny for some new devices.
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Janssen seeks FDA approval for canagliflozin as Type 2 diabetes treatment
RARITAN, N.J. — A Johnson & Johnson subsidiary is seeking approval for a Type 2 diabetes treatment.
Janssen Research and Development has submitted a new drug application to the Food and Drug Administration for the approval of canagliflozin — an investigational oral, once-daily, selective sodium glucose co-transporter 2 inhibitor — for use in adult patients. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels, the company said.
The filing was supported by a comprehensive global phase-3 clinical development program, which included nine multicenter, randomized clinical studies that enrolled approximately 10,300 patients. The late-stage clinical trial evaluated the safety and efficacy of canagliflozin across the spectrum of Type 2 diabetes and included placebo- and active comparator-controlled studies. The program also included a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease.
Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma. Janssen Pharmaceuticals has marketing rights in North America, South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.
According to this article, http://www.rxwiki.com/news-article/canagliflozin-type-2-diabetes-closer-approval-may-have-safety-issues Researchers found that the drug was able to lower blood sugar levels but may increase the risk of heart, kidney and bone-related problems. But how do you decide if it's worth the risk?
Navarro Discount Pharmacy launches Spanish-language site
MIAMI — Hispanic-owned pharmacy chain Navarro Discount Pharmacy has added a Spanish-language version to its website at Navarro.com.
“The new Spanish-language content allows us to better serve loyal customers already familiar with the Navarro brand and reach out to the millions of U.S. Hispanics who are online today,” stated Gus Milla, director of e-commerce for Navarro Discount Pharmacy. “Proud of their Hispanic origins, these Hispanics are in search of products familiar to them from their countries of origin, such as food, tea, nectars and cola, soap, cleaners and [such] entertainment [as] domino tables and cards.”
Navarro.com En Español includes video and media content on family- and health-related topics plus product reviews, prescription management tools and e-commerce purchasing capabilities for all of its signature products. Customers may refill prescriptions, check order status and purchase such products as Cuban coffee, pastelitos, ethnic cookies, Cuban bread, domino tables, OTC and beauty products.
In addition, the entire line of Vida Mia private-label bilingual products in English and Spanish, including more than 300 product SKUs, also are available at Navarro.com En Español. Vida Mia’s product categories include household, beauty, food, body, baby and OTC. It is estimated that nearly 30 million U.S. Hispanics currently are online, many of them native-born Hispanics rather than immigrants.
Online orders are processed immediately through Navarro’s fulfillment center in Miami. Navarro.com accepts all major credit cards, and free shipping is available for online orders of $25 or more.
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