Regulatory and Washington

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

Par announced the launch of a generic version of Provigil (modafinil), used to treat such sleep disorders as narcolepsy and work shift sleep disorder.

ATLANTA — Sales of smoking-cessation products may realize a March boom following a recent government advertising campaign that encourages Americans to quit smoking.

One week following the Centers for Disease Control and Prevention's launch of its Tips from Former Smokers campaign, calls to the 1-800-QUIT-NOW quitline were up 130.4%, the agency reported Monday. Calls were up an additional 3.5% in the subsequent week.

A record 34,413 calls were fielded between March 26 and April 1, the CDC reported.

JERUSALEM — Teva is the first company to file for a generic version of a drug used to treat sleep disorders, the Food and Drug Administration has determined, though Mylan is contesting the FDA decision.

BETHLEHEM, Pa. — OraSure Technologies on Wednesday announced that the Food and Drug Administration's Blood Products Advisory Committee will consider making its OraQuick Rapid HIV-1/2 test available over the counter on May 15.

At the meeting, OraSure will present its consumer-usage studies — approximately 5,800 subjects were enrolled and tested in this phase across 20 states, the company said, which helped identify more than 100 previously undiagnosed individuals.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores has submitted official comments to the Centers for Medicare and Medicaid Services regarding its proposed rule on Medicaid pharmacy reimbursement using the average manufacturer price model. The AMP model was reformed by the Patient Protection and Affordable Care Act.

PARSIPPANY, N.J. — A court has ruled that patents covering a drug designed to treat an overactive bladder are invalid, a company looking to launch a generic version of the drug said.

Watson Pharmaceuticals said the U.S. District Court for the District of Delaware ruled that five patents covering Allergan's Sanctura XR (trospium chloride) extended-release capsules were invalid. Watson's application with the Food and Drug Administration for a generic version are pending, the company said.

ATLANTA — The Food and Drug Administration has approved a patch for treating restless legs syndrome and Parkinson's disease.

UCB announced the FDA approval of Neupro (rotigotine) transdermal system advanced-stage idiopathic Parkinson's and moderate-to-severe restless legs syndrome.

PARSIPPANY, N.J. — Watson is challenging the patent protection on two eye drugs made by Allergan, the generic drug maker said Tuesday.

Watson announced that it had filed with the Food and Drug Administration for generic versions of Allergan's Lumigan and Latisse (bimatoprost) ophthalmic solution. The products contain the same active ingredient in the 0.01% and 0.03% strengths, respectively, and are used to reduce pressure within the eye in patients with open-angle glaucoma or ocular hypertension.