FDA approves new Teva contraceptive
JERUSALEM — The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.
The drug maker announced the approval of Quartette (levonorgestrel, ethinyl estradiol and ethinyl estradiol) tablets. Teva said the drug represented the "next generation" of extended-regimen oral contraceptives and was designed to minimize breakthrough bleeding between scheduled periods.
"Breakthrough bleeding can be experienced with any birth control pill, especially during the first few months, and is one of the reasons a large number of women discontinue extended regimens," George Washington School of Medicine professor of obstetrics and gynecology James Simon said in a statement on behalf of Teva. "The estrogen in Quartette increases at specific points and provides four short light periods a year. Breakthrough bleeding decreases over time, which might help encourage patient adherence."
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Actavis seeks approval for additional strength of generic testosterone gel
PARSIPPANY, N.J. — Just a week after the Supreme Court heard the Federal Trade Commission’s lawsuit over its deal with AbbVie to sell a generic version of a testosterone-replacement therapy, Actavis is challenging the patent on another strength of the drug.
Actavis said Monday that it had filed with the Food and Drug Administration for approval of testosterone gel in the 1.62% strength. The drug is a generic version of AbbVie’s AndroGel 1.62%. The case that went before the Supreme Court on March 25 concerns the 1% strength of AndroGel.
AbbVie subsidiary Unimed Pharmaceuticals and another company, Besins Healthcare, filed suit against Actavis Friday in the U.S. District Court for the District of Delaware to prevent commercialization of the generic, alleging that Actavis’ FDA application violates a patent scheduled to expire in August 2020. The lawsuit puts a stay of FDA approval on the drug for up to 30 months, unless the companies reach a settlement.
AndroGel 1.62% had sales of about $690 million during the 12-month period that ended in January, according to IMS Health.
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FDA approves J&J diabetes drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Johnson & Johnson for treating Type 2 diabetes, the agency said.
The FDA announced the approval of J&J subsidiary Janssen Pharmaceuticals’ Invokana (canagliflozin) tablets, designed for use with diet and exercise to improve blood-sugar control in adults with the disease.
"Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 inhibitors," FDA Division of Metabolism and Endocrinology Products director Mary Parks said. "We continue to advance innovation with the approval of the new drug classes that provide additional treatment options for chronic conditions that impact public health."
The drug works by blocking the kidney from reabsorbing blood-sugar, also known as glucose, thereby increasing glucose excretion and lowering blood-glucose levels.