FDA grants Astellas NDA for tacrolimus extended-release capsules
NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration’s review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.
The NDA submission is based on six randomized and comparative studies of 2,842 (1,689 tacrolimus extended-release) kidney transplant recipients and 689 (393 tacrolimus extended-release) liver transplant recipients conducted in the United States, Canada, Europe, Australia, Brazil and New Zealand, among other sites. Based upon the September receipt of the NDA submission, the FDA Prescription Drug User Fee Act review date will be July 21, 2013.
"The NDA acceptance for tacrolimus extended-release capsules marks an important step toward addressing the unmet treatment need for transplant recipients who have difficulty controlling their immunosuppression drug levels with existing products," said Roy First, Astellas Global Therapeutic Area Head for Transplantation. "Astellas has been committed to the field of immunology for more than 20 years and plans to continue that commitment by working to bring promising new treatments for patients to market."
Astellas US is a subsidiary of Tokyo-based Astellas Pharma, a pharmaeutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
The NDA submission is based on six randomized and comparative studies of 2,842 (1,689 tacrolimus extended-release) kidney transplant recipients and 689 (393 tacrolimus extended-release) liver transplant recipients conducted in the United States, Canada, Europe, Australia, Brazil and New Zealand, among other sites. Based upon the September receipt of the NDA submission, the FDA Prescription Drug User Fee Act review date will be July 21, 2013.sms lån
AffordRx makes prescription-discount card available nationwide
DALLAS — AffordRx.com is making a prescription discount card that offers savings of up to 75% at more than 56,000 pharmacies across the country available to all residents of the United States, the company said.
The company said the cards would be available without restrictions on membership and that there were no income requirements, age limitations or applications.
"We are excited to launch this program, potentially saving Americans millions of dollars on their prescription medication," AffordRx spokesman Dylan Marc said.
The program was launched to help uninsured and underinsured people afford prescription drugs, but is also available to people with health insurance with no prescription benefits, which is common among many health savings accounts and high-deductible health plans.
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Ready for globalization of drug retailing?
CVS Caremark is looking to acquire an 80% stake in Onofre, the eighth-largest pharmacy chain in Brazil, according to published reports.
Are you ready for the globalization of drug store retailing? DSN is. And we expect it to continue. Why? That’s where the Rx growth is. Expect more of these deals. Where? Follow the money (i.e., emerging markets where Rx growth is still in high single- to low double-digits).
There are no substantial retail acquisitions left to make within the United States, so CVS could opt to grow organically in places like the Pacific Northwest, where it has no presence, or set its sights on emerging international markets where pharmacy growth is still robust.
What’s interesting about the deal — aside from the obvious fact that it marks the retailer’s first major expansion outside of the United States — is its simplicity and sensibility. Snapping up the 44-store Brazilian retailer enables CVS to expand its core retail pharmacy business via a manageable platform without the hassle of any complex financial arrangements, a fact that Pembroke Consulting’s Adam Fein also made note of Friday morning in his blog Drug Channels.
In fact, this is precisely the type of deal that some industry observers anticipated that CVS might make, as exporting the PBM model could prove quite challenging. Perhaps the PBM model would prove difficult to export but with all the growth in markets such as Brazil there is still plenty of profit to be made filling scripts at retail and selling merchandise on the front-end in these emerging markets.
Meanwhile, Walgreens expects to continue to expand throughout Europe, Asia and eventually will look to enter South America, company executives have noted.
Actually, further European pharmacy expansion will be difficult for Walgreen or Boots. In most EU countries, pharmacy chains are either prohibited or severely restricted. Many countries require pharmacist ownership, e.g., France, Greece, Italy and Spain. Most EU countries also restrict the number of pharmacies under common ownership, or limit ownership to minority stakes beyond the first one. For example, Italy prohibits ownership of more than one pharmacy, while France limits chain size to 5 pharmacies. Boots already has a strong presence in the minority of EU countries that permit unlimited pharmacy chains (UK, Ireland, Norway). Adam Fein Drug Channels