FDA approves Adempas to treat pulmonary hypertension
SILVER SPRING, Md. — The Food and Drug Administration today approved Adempas, also known as riociguat, to treat adults with two forms of pulmonary hypertension, which is caused by abnormally high blood pressure in the arteries of the lungs.
Adempas is intended for patients with chronic thromboembolic pulmonary hypertension, or CTEPH, after surgery or patients who cannot undergo surgery, to improve their ability to exercise. Adempas is also indicated for patients with pulmonary arterial hypertension, or PAH, of unknown causes, inherited or associated with connective tissue diseases, to improve their ability to exercise and to delay clinical worsening of their condition.
“Adempas is the first in its drug class approved to treat pulmonary hypertension and the first drug of any class to be shown to be effective for patients with CTEPH,” said Norman Stockbridge, director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research.
Adempas will carry a boxed warning alerting patients and healthcare professionals that the drug should not be used in pregnant women because it can harm the developing fetus. Female patients can receive the drug only through the Adempas REMS program. All female patients must be enrolled in the program, comply with pregnancy testing requirements and be counseled regarding the need for contraception. The REMS restricted distribution program also requires prescribers and pharmacies to be certified by enrolling in the program.
Ala. GOP representative proposes stopgap bill to fund FDA
NEW YORK — A Republican congressman from Alabama has proposed a stopgap bill that would fund the Food and Drug Administration through the middle of December or until the government shutdown ends, though it is unlikely to pass in the Senate.
Last week, Rep. Robert Aderholt proposed the joint resolution, designed to ensure that the agency continues to receive funding until Dec. 15 or until the shutdown ends. However, Senate majority leader Harry Reid has said he will oppose such short-term funding bills. The federal government has remained shut down since Oct. 1, when Congress and the White House failed to reach an agreement on a fiscal year 2014 budget; Republicans in Congress have insisted that any budget agreement be tied to a delay or defunding of the Patient Protection and Affordable Care Act.
As part of its contingency staffing plan announced at the beginning of this month for the shutdown, the Department of Health and Human Services said the FDA would continue "limited" activities related to user-fee funded programs — such as reviews of generic drug applications — and such vital activities as consumer protection and high-risk recalls.
Lupin launches generic Zymaxid ophthalmic solution in the U.S.
BALTIMORE — Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan’s Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.
Zymaxid had annual U.S. sales of approximately $62.3 million. As the first applicant to file an ANDA for Zymaxid, Lupin will be entitled to 180 days of marketing exclusivity.
Commenting on the approval, Nilesh Gupta, managing director Lupin Limited, said, "Having received approval earlier, we are happy to now launch this product. The product is the first of the ophthalmic products that Lupin is bringing to the market and bears testimony to our continued commitment to serving our customers and patients by bringing high-quality, affordable medicines."