Regulatory and Washington

ALEXANDRIA, Va. — Two lobbying groups representing the nation's pharmacies are emphasizing how community pharmacies can help lower prescription drug costs, as well as the importance of maintaining the right of military families and veterans to choose where they fill their prescriptions through the Tricare program.

WASHINGTON — Life…supplemented on Thursday announced its fundraising initiative, “Why You Want to Be Well,” for Vitamin Angels for March, and will use Facebook to raise up to $5,000.

KARMIEL, Israel — The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

The company said the FDA issued a complete response letter for its application for taliglucerase alfa, a treatment for Gaucher disease. The FDA issues a CRL when it has finished reviewing a regulatory application, but questions remain that preclude final approval.

PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

PRINCETON, N.J. — Novo Nordisk has filed for approval of a treatment for a rare genetic bleeding disorder, the Danish drug maker said Wednesday.

The company submitted to the Food and Drug Administration its application for recombinant factor XIII compound, for congenital factor XIII deficiency. Current treatments for FXIII deficiency use products derived from human blood plasma, which carries the risk of contamination.

OSAKA, Japan — Drug maker Takeda has filed for regulatory approval of a drug to treat hypertension, the company said Wednesday.

Takeda announced that it had submitted an application with the Food and Drug Administration for the fixed-dose drug azilsartan medoxomil and chlorthalidone. Azilsartan medoxomil is an angiotensin II receptor blocker, or ARB, that lowers blood pressure by blocking the angiotensin II hormone.

WASHINGTON — The Natural Products Association on Wednesday announced the promotion of Cara Welch to VP scientific and regulatory affairs.

“Welch has been a major contributor to achieving the success of both our Natural Seal and GMP certification programs, and she is the perfect choice to lead this department,” stated John Gay, NPA executive director and CEO. “The NPA Natural Seal has been a huge success, with nearly 600 certifications since its launch in 2008.”

MONROVIA, Calif. — Biotab Nutraceuticals on Tuesday initiated a voluntary recall of two lots of Extenze nutritional supplement tablets.

Some packages bearing lot numbers 0709241 and 0509075 are counterfeit products containing undeclared drug ingredients that can pose a serious risk to health, the company stated.