Regulatory and Washington

WASHINGTON — U.S. Sens. Pat Roberts, R-Kan., and Mary Landrieu, D-La., on Tuesday introduced legislation that repeals a portion of Obamacare that prohibits people from using their medical savings account funds to buy over-the-counter medications. Under current law, plan participants may no longer use funds from these accounts to purchase OTC medications, unless they have a prescription for the medication.

NEW YORK — State legislators in Michigan are considering a bill that would allow pharmacies to sell medical marijuana, according to published reports.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

The FDA approved Mylan's tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.

The drug is a generic version of Pfizer's Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.

SILVER SPRING, Md. – The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

The FDA approved Emcure's vancomycin hydrochloride injection in the 5-g-per-vial strength.

The drug is a generic version of Vancocin, made by ViroPharma.

ATLANTA — Drug maker UCB is seeking approval for one of its drugs as a stand-alone therapy for epilepsy.

The company said Monday that the Food and Drug Administration had accepted its regulatory approval application for Vimpat (lacosamide) for adult epilepsy patients with partial-onset seizures. The drug is already approved as an add-on therapy for partial-onset seizures in patients aged 17 and older.

NEW YORK — A proposal by the Texas State Board of Pharmacy to eliminate the required ratio of pharmacy technicians to pharmacists in retail pharmacies in the state has drawn mixed responses from professional and industry trade groups.

Currently, the required ratio is three technicians to one pharmacist, which the board's proposal would remove for retail pharmacies, known under Texas law as "Class A" pharmacies. In response, the Texas Pharmacy Association has proposed an interim ratio requirement of four technicians to one pharmacist.

ALLEGAN, Mich. —  Perrigo on Friday initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings. 

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a new injectable painkiller made by Becton, Dickinson and Co., the medical products manufacturer said Monday.

BD announced the FDA approval of morphine sulfate injection as part of its BD Simplist line of ready-to-administer pre-filled injectables. The drug was approved in the 2-mg-per-mL, 4-mg-per-mL, 5-mg-per-mL, 8-mg-per-mL and 10-mg-per-mL strengths.