FDA approves first Crestor generic
SILVER SPRING, Md. — The Food and Drug Administration on Friday announced that it had approved a generic of AstraZeneca’s Crestor (rosuvastatin calcium). The generic, from Allergan, is the first to be approved for blockbuster Crestor, which saw $6.5 billion in annual sales for the 12 months ended March 31, according to IMS health.
The drug is indicated to treat high triglycerides, dysbetalipoproteinemia and high LDL cholesterol. It was approved in 5-, 10, 20-, and 40-mg dosage strengths, according to the FDA.
“The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments,” said Dr. Kathleen Uhl, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.
In 2013, Actavis said it would launch its generic 67 days before July 8 — the day that Crestor’s pediatric exclusivity expires.
Takeda expands patient assistance program in U.S.
DEERFIELD, Ill. — Takeda Pharmaceuticals on Thursday announced that it would be expanding its Help At Hand patient assistance program for patients in the United States.
The expansion will allow patients whose income is at 400% of the federal poverty level to apply for discounted or no-cost medicine under the program, which currently includes 11 of the company’s drugs. Under the expansion, a family of four whose household income is about $100,000 is now eligible for the prescription drug program.
"We have expanded this program to allow more U.S. patients to gain access to Takeda medicines that can potentially improve their health,” Takeda Pharmaceuticals U.S.A president Ramona Sequeira said. “Every day, we’re placing the needs of patients at the center of what we do around the world. This program expansion in the U.S. is one more way we’re showing patients we’re focused on their needs.”
FDA expands indication for Teva’s ProAir RespiClick
SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Teva’s ProAir RespiClick (albuterol sulfate) inhalation powder to treat or prevent bronchospasm in children aged 4 to 11 years. The drug had previously been approved for the same indication in patients older than 12.
The drug is the only breath-activated multi-dose short-acting beta agonist, inhaler in the U.S., Teva said.
“We are very pleased with the FDA’s decision to expand the indication of ProAir RespiClick for the treatment of patients as young as four years of age,” Teva SVP global respiratory research and development Dr. Tushar Shah said. “The availability of this treatment option for younger patients is a demonstration of Teva’s commitment to optimizing respiratory therapies through the development of new delivery systems that help address needs in the marketplace.”
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