Regulatory and Washington

NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker's application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.

LISLE, Ill. — SXC Health Solutions announced Wednesday that it had completed its acquisition of independent specialty pharmacy provider MedfusionRx in a deal worth $100 million in cash, with an additional $5.5 million subject to the achievement of certain performance targets in fiscal year 2012.

The waiting period under the Hart-Scott-Rodino Act expired Dec. 24.

WASHINGTON — Though most might associate the Internal Revenue Service with the Grinch, the IRS came through with a last-minute Christmas present for retailers stung by changes in the tax code related to consumers’ use of flexible spending and health reimbursement accounts to purchase approved OTC products.

MORRISTOWN, N.J. — The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

Watson's new oral contraceptive is positioned as a novel alternative to currently available birth control pills, and the dosing combination and 24-day active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Tuesday ruled that Procter & Gamble provided reasonable support for claims that Prilosec OTC provides “superior acid control” over a competing product, Prevacid 24HR. However, the NAD recommended P&G discontinue a comparative claim made in a context that doesn’t reference acid control, the review board added.

P&G’s Prilosec OTC claims were challenged by Novartis Consumer Health, maker of Prevacid 24HR. Claims at issue included:

WASHINGTON — The House of Representatives on Wednesday passed the Food Safety Modernization Act by a vote of 215-144 to wide industry aplomb.

The bill now only needs President Barack Obama’s signature to become law.

If signed into law, the food safety bill will require biennial registration of all food manufacturing facilities, will provide the Food and Drug Administration with new authority to mandate food recalls and will require companies to develop food safety plans.

NEW YORK — Pfizer on Monday announced that it intends to recall one lot — approximately 19,000 bottles — of Lipitor 40-mg tablets (atorvastatin calcium) distributed in the United States because of one customer’s report of an uncharacteristic odor related to the bottles in which these lots of Lipitor were packaged.

The bottles were supplied by a third-party bottle manufacturer. A medical assessment found that the risk of health consequences to patients appears to be minimal, Pfizer reported.

BRISTOL, Tenn. — Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

The two drug makers announced Tuesday the submission for Acurox (oxycodone hydrochloride), an immediate-release tablet for relief of moderate to severe pain.

The tablets use Acura’s aversion technology, designed to deter abuse of the drug by dissolving or crushing the pills.