Shares of Cumberland Pharmaceuticals (CPIX) are having a rough go of it after the Food and Drug Administration (FDA) outlined some concerns that will further delay a ruling on its liver drug. The regulatory agency already postponed its decision from August to December, and now the FDA says it needs additional data before it can recommend the drug for approval.

In its complete response letter to Cumberland, the FDA noted insufficient evidence to prove that the injectable drug, Acetadote, is effective in all patients. Cumberland said it plans to meet with the FDA soon to address the outstanding issues.

Mela Sciences (MELA) gapped higher right out of the gate Monday, with the shares surging roughly 12% on Monday morning. Over the weekend, Barron's noted that the stock is "worth a close look ahead of a regulatory vote on Nov. 18," and traders are apparently taking the suggestion to heart.

The financial publication described its opinion on the shares as "cautiously optimistic," explaining that analysts believe MELA could double if its MelaFind device receives the OK from a Food and Drug Administration (FDA) panel this Thursday. However, warned Barron's, a regulatory thumbs-down "could cut the shares in half."

Arena Pharmaceuticals (ARNA) is taking a serious beating, with the stock down about 40% at last look. Traders are reacting to new concerns raised by the Food and Drug Administration (FDA) over Arena's experimental obesity drug, lorcaserin. Following an initial review, FDA staff cited "three noteworthy safety issues" with lorcaserin: heart valve disease, psychiatric and memory problems, and excessive tumors in rats.

The drug met one of the FDA's effectiveness standards "by a slim margin," with 47% of study participants shedding 5% or more of their body weight -- but lorcaserin fell short on another measure of effectiveness. Patients treated with lorcaserin in a study experienced just 3% greater weight loss than patients treated with a placebo, falling short of the FDA's 5% benchmark.

The Food and Drug Administration (FDA) recently gave Shire Plc (SHPGY) shareholders something to smile about when it approved Daytrana for treating patients between 13 and 17 years who suffer from Attention Deficit Hyperactivity Disorder (ADHD).

Daytrana is the only ADHD treatment that is available in a transdermal patch, which delivers methylphenidate through the skin into the bloodstream. It is already approved for use by patients between 6 and 12 years.

With this announcement, Shire -- which licensed Daytrana from Noven Pharmaceuticals -- stands to gain market share and increase revenues.

AstraZeneca (AZN) is in a race against time to develop new drugs as patent expiration dates are looming for some of its most profitable medicines over the next few years.

The company had hoped that motavizumab -- a medicine that is supposed to help prevent respiratory disease in infants -- would be one of the drugs to issue in a new era of profits by replacing Synagis -- a patented drug that fights the same virus. Unfortunately for AstraZeneca, that may not happen.

Depomed Inc. (NASDAQ: DEPO) opened Monday on a loss of nearly 50%, as traders panned the company's clinical trial results for Serada. The drug, which is intended to treat hot flashes related to menopause, met only one one of four co-primary goals in late-stage trials after 12 weeks.

Depomed was hoping to prove that Serada could help patients achieve a "statistically significant reduction in the frequency and severity of menopausal hot flashes." However, the company confessed that the placebo effect was unexpectedly high in clinical studies.

The U.S. Food and Drug Administration (FDA) has some questions for Genzyme Corp. (NASDAQ: GENZ) regarding trial data for its leukemia drug, Clolar. Because Genzyme didn't follow the FDA's recommendations in conducting its main study of Clolar, the regulatory agency is reluctant to make a decision on the basis of the trial results.

In 2007, FDA staff advised Genzyme to conduct a randomized study in which participants receiving Clolar would be compared against a set of patients not receiving the drug. However, the drug company's primary tests did not include a control group; instead, the treatment was tested only on elderly patients with acute myeloid leukemia (AML).

Matrixx Initiatives (NASDAQ: MTXX), maker of the allegedly scent-stealing Zicam nasal swabs, tumbled to a new annual low this morning on news that the Securities and Exchange Commission (SEC) is launching an informal inquiry. The SEC is requesting documents and other information regarding the warning letter issued to Matrixx by the U.S. Food and Drug Administration.

Last week, the FDA told consumers to stop using certain nasally administered Zicam products after the agency received more than 130 complaints from users who lost their sense of smell. Matrixx has defended its homeopathic, over-the-counter offerings, calling the safety concerns "erroneous," but the firm settled hundreds of lawsuits in 2006 with consumers making the same allegations.

In yet another case of product contamination, Colgate-Palmolive (NYSE: CL) has discovered counterfeit packages of its Colgate-brand toothpaste on the shelves of discount stores in New York, New Jersey, Pennsylvania, and Maryland.

A statement noted that, "There are indications that this product does not contain fluoride and may contain [poisonous chemical] diethylene glycol." So . . . it won't clean your teeth, but it might make you sick or worse. Lose-lose.

Diethylene Glycol, used as a solvent and in antifreeze, has been "improperly used as a low-cost substitute for glycerin and propylene glycol in pharmaceutical preparations," according to a June 8 statement from the U.S. Food and Drug Administration (FDA). Certain toothpastes imported from China in recent weeks have been found to contain the potentially deadly substitute ingredient; the FDA is advising consumers to discard any toothpaste labeled as made in China.

Fortunately, there is clue for any concerned residents of the targeted states. The impostor Colgate tubes are labeled "Manufactured in South Africa" -- but CL does not import toothpaste into the U.S. Proving that criminals aren't always masterminds, the fake tubes have also been found to contain misspellings, such as the "South African Dental Assoxiation" or "SOUTH AFRLCA."

Beth Gaston Moon is an analyst at Schaeffer's Investment Research.