Content about Regulatory and Washington

PHILADELPHIA — The Food and Drug Administration has approved a generic version of a short-term adjunct treatment for obesity.

Lannett said that the FDA approved its abbreviated new drug application for phentermine resin extended-release capsules in the 15-mg and 30-mg strengths. The drug, which is equivalent to UCB's Ionamin, will be sold in bariatric clinics.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has asked Eisai to redo its regulatory application for a drug to treat epilepsy, Eisai said Friday.

The drug maker said the FDA issued a refusal to file letter in response to its application for perampanel, designed to treat partial-onset seizures in patients with epilepsy. In the letter, the FDA requested reformatting and reanalyses of some datasets, though Eisai said new studies probably were unnecessary.

JERUSALEM — Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

Teva announced the launch of Camrese, an authorized generic of Duramed’s Seasonique (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets).

The launch of Teva’s authorized generic follows the launch of Watson Pharmaceuticals’ generic version of the drug, which it is marketing under the name Amethia.

WASHINGTON — Sens. Ben Cardin, D-Md., and Mike Enzi, R-Wyo., last week introduced the Medical Flexible Spending Account Improvement Act (S. 1404), a bill that would allow consumers to pay taxes on and withdraw any remaining funds in their employer-sponsored flexible spending accounts.

Current rules require that any leftover balance in an FSA must be forfeited to the employer at the end of the plan year, oftentimes identified as the "use it or lose it" provision.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Thursday that it submitted comments to the U.S. Senate Health, Education, Labor and Pensions Committee, which held a hearing Thursday titled "FDA User Fees: Advancing Public Health," outlining community pharmacy's commitment to addressing drug safety and the appropriate use of prescription medications to help improve patient health.

WASHINGTON — The Patient Protection and Affordable Care Act is producing savings for state Medicaid programs that take advantage of a provision equalizing drug rebates between managed care and fee-for-service programs, according to a fact sheet released Tuesday by the Association for Community Affiliated Plans.

HAYWARD, Calif. — The branded drugs division of Impax Labs has finished enrolling patients in a late-stage trial of a drug for Parkinson’s disease.

Impax Pharmaceuticals said Tuesday that it had enrolled patients in ASCEND-PD, a phase-3 trial of IPX066 that will compare the drug with carbidopa-levodopa and entacapone in patients with advanced Parkinson’s. IPX066 is an extended-release formulation of carbidopa-levodopa in capsule form.

OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical is reapplying for approval of two drugs to treat Type 2 diabetes after the Food and Drug Administration turned down its last applications, the company said.

Takeda announced that it resubmitted its applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in Actos, which the FDA approved in 1999.

The FDA will review the applications over the next six months, the drug maker said.

SUPPLIER NEWS — Unilever has announced changes to its category and go-to-market structure to further support its growth plans and allow for a more efficient rollout of increasingly bigger and more scalable innovations. The changes include several executive moves, including the appointment of Dave Lewis, president of the Americas, as president of personal care, consisting of skin, deodorants, oral and hair.


PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to be the first to market a generic version of a GlaxoSmithKline drug for men with an enlarged prostate, Watson said.

Watson announced that it filed a regulatory approval application to market a generic version of GSK’s Jalyn (dutasteride and tamsulosin hydrochloride) capsules, a treatment for symptomatic benign prostatic hyperplasia in men with enlarged prostates.

ROCKVILLE, Md. — The Food and Drug Administration on Friday refreshed its Consumer Updates page with information regarding the danger of acetaminophen overdose in children.

“You’re in the drug store, looking for a fever-reducing medicine for your children,” the message begins. “They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest.”

ALEXANDRIA, Va. — Bipartisan legislation recently introduced to the Senate has received endorsement from a group representing the retail pharmacy industry.