News In Brief

Allegra available OTC nationwide

Sanofi-Aventis' Allegra products are now available over-the-counter, the company announces March 8. FDA approved the switch Jan. 24 (Also see "Sanofi Allegra Switch Approval Triggers Race To Market For Perrigo" - Pink Sheet, 31 Jan, 2011.). Allegra 12-Hour, 24-Hour, Children's Allegra 12-Hour Orally Disintegrating Tablets, 12-Hour Oral Suppression and 12-Hour Tablets are available OTC. Allegra-D 24-Hour and 12-Hour, which contain pseudoephedrine, are available behind the counter from a pharmacist. Pricing is at retailers' discretion. A 30-tablet package of Allegra D 24-Hour sells for $22.99 before promotions, according to drugstore.com. The site sells 30-count packs of McNeil Consumer Healthcare's Zyrtec for the same price. A 40-pack of Merck's Claritin retails for a suggested price of $29.99.

Generic Mucinex not in Watson's guidance

Watson Pharmaceuticals did not include its generic Mucinex launch in its 2011 earnings guidance, Chief Financial Officer Todd Joyce says. Speaking March 8 at the Cowen & Co. Healthcare Conference, Joyce echoed previous execs who noted the firm has not decided how to market store-brand guaifenesin .

FDA flags NutraSilver for MRSA claims

Beneficial Solutions' claims for NutraSilver make the supplement an unapproved new drug, FDA's San Francisco district office says in a Feb. 18 letter. FDA found the claims, including "proven to eliminate Lyme disease symptoms" and "a fast and effective MRSA/MERSA Disease Treatment," when reviewing www.nutrasilver.com and other marketing materials. The drug does not include adequate directions for use because it purports to treat conditions not amenable to self-diagnosis, FDA tells the Reno, Nev., firm.

Consumer product sales drive Hi-Tech profit

A 27% increase in consumer product sales helped drive Hi-Tech Pharmacal's overall 29% growth in net sales to $50 million in its fiscal 2011 third quarter. The Amityville, N.Y., firm March 10 said sales of the Mag-Ox line of magnesium supplements, which it acquired in March 2010, were key drivers in the Health Care Product division's $3.7 million in sales during the November-January period ("Hi-Tech adds magnesium supplements," "The Tan Sheet" March 8, 2010, In Brief). Net income was up 18.8% from the year-ago period to $10.1 million and diluted earnings per share grew at a similar rate to 79 cents, the firm said. According to the earnings release, Hi-Tech expects to take a $400,000 hit from removing its Lodrane prescription product from the market as required by FDA's March 2 enforcement order against unapproved cough, cold and allergy drugs (Also see "OTC Monograph Offers Redemption For Some Unapproved Cough/Cold Drugs" - Pink Sheet, 7 Mar, 2011.).

Mannatech losses continue

Mannatech reports net losses for both the fourth quarter and its full fiscal 2010. The Coppell, Texas, direct-sales firm lost $2.7 million in the October-December period and $10.6 million in the full year, which equals 40 cents per diluted share. Co-CEO and Chief Science Officer Robert Schmidt touted "prudent international expansion" with the launch of operations in Mexico on Jan. 24. The firm added 23,196 independent sales associates in the quarter, a drop from the previous quarter. The company has posted losses for several quarters ( (Also see "Sales & Earnings In Brief" - Pink Sheet, 8 Nov, 2010.), Sales & Earnings In Brief).

Report shows economic benefit of FDA

The Alliance For A Stronger FDA highlights the agency's importance to the national economy in a white paper released as Congress negotiates budget cuts. Biopharma and medical device industry workers earn high wages, and a strong FDA with "expeditious approval of safe and effective new products" helps drive U.S. exports of medical technologies, the group says. The Alliance also says FDA oversight of food is "one of the brightest spots in the U.S. industrial landscape." The paper is intended to remind policymakers of FDA's role in the economy, the group says. Federal agencies face sharp budget cuts as lawmakers negotiate spending for the remainder of fiscal 2011 (Also see "Cuts For Federal Government, FDA Loom As Budget Fights Continue" - Pink Sheet, 7 Mar, 2011.).