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LIVINGSTON, N.J. and PARSIPPANY, N.J. — Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.

Columbia Labs said Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to the application for progesterone vaginal gel 8%. Late last month, the drug received a thumbs-down from an FDA panel that declined to recommend approval for it.

The FDA is expected to take action on the NDA by Feb. 26.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a Merck drug designed to reduce elevated intraocular pressure in patients with certain eye conditions, the company announced.

Zioptan (tafluprost ophthalmic solution), a preservative-free prostaglandin analog ophthalmic solution, is designed to reduce IOP in those with open-angle glaucoma or ocular hypertension, which respectively are the most common form of glaucoma and increases in pressure inside the eye.

DUBLIN, Calif. — An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

The FDA's Oncologic Drugs Advisory Committee voted 10-3 with one abstention not to support the risk-benefit profile of Dacogen (decitabine) in certain elderly patients with acute myeloid leukemia. The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued a public warning that the use of proton-pump inhibitors or H2 blockers may be associated with an increased risk of Clostridium difficile–associated diarrhea, or CDAD.

Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve, the agency stated.

BRIDGEWATER, N.J. — The Food and Drug Administration has approved a head lice treatment made by Sanofi, the drug maker said.

Sanofi announced the approval of Sklice (ivermectin) lotion in the 0.5% strength for patients ages 6 months and older. According to Sanofi, head lice infest an estimated 6 to 12 million children ages 3 to 11 years and costs as much as $1 billion in lost school days and lost work for parents.

DEERFIELD, Ill. — Takeda Pharmaceutical has launched a drug for treating high blood pressure in adults, the company said.

Takeda announced the availability of Edarbyclor (azilsartan medoxomil and chlorthalidone), a once-daily tablet for the condition, also known as hypertension.

RIDGEFIELD, Conn. — An antiplatelet medication created by Boehringer Ingelheim is not affected when co-administered with a proton-pump inhibitor, according to results of a drug interaction study.

NEW YORK — While the financial burden that families face due to prescription drugs has declined, costs nevertheless remain a challenge for many of them, according to a new study by nonprofit research organization Rand Corp.