FDA gives tentative approval for Perrigo OTC pain drugs
ALLEGAN, Mich. The Food and Drug Administration has given Perrigo tentative approval for its OTC ibuprofen and diphenhydramine citrate tablets, Perrigo announced Wednesday.
The product, available in 200 mg and 38 mg doses, will be sold under private labels and is comparable to Wyeths Advil PM pain-relief tablets.
“This is another example of Perrigo’s investment in new products making quality healthcare more affordable to American consumers,” Perrigo chairman and chief executive officer Joseph Papa said in a statement. “This is an important addition to our portfolio of products that saves the consumer of our OTC healthcare products approximately $1 billion annually when compared to the higher priced national brands.”
Biocodex releases Florastor in 20-count packs in time for cold-flu season
SAN BRUNO, Calif. Biocodex has announced that its Florastor digestive health probiotic product now is available in 20-count blister packs for retail sale. The smaller box is easier to carry and more convenient than the larger size glass bottle of 50 capsules.
The key ingredient—Saccharomyces boulardii—in yeast-based Florastor and Florastor Kids helps protect the guts by promoting “good bacteria” to aid in digestion.
Probiotics can help as a supplemental treatment for those taking antibiotics which can have severe, uncomfortable side effects, such as diarrhea.
Biocodex explained that the updated packaging was designed for portability and availability on chain drug store shelves.
“We’re very excited about our change in packaging with the new Florastor blister packs,” Mary Berry, U.S. marketing manager for Biocodex said. “We felt our consumers would prefer a 20-count box because, at two capsules per day, it coincides with the standard 10-day course of antibiotics to protect against antibiotic-associated diarrhea, a common side effect of antibiotic treatment. The blister packs make it easier for people to protect their stomachs by carrying Florastor with them wherever they are.”
FDA issues warning to Bayer regarding sale of not-yet-approved aspirins
WASHINGTON The Food and Drug Administration has issued warning letters to Bayer HealthCare concerning two unlawful, OTC aspirin products, the agency said in a release Tuesday.
The two products, Bayer Women’s Low Dose Aspirin Plus Calcium and Bayer Aspirin with Heart Advantage contain aspirin with either calcium or phytosterols and are unapproved new drugs requiring an approved application for the company to market them, the FDA said. In addition to being labeled for use as pain relievers, both are labeled as reducing the risks of heart disease. Bayer Women’s is also labeled for use in fighting osteoporosis. Still, the FDA has not approved either product for these uses.
“The FDA considers these products new drugs, and thus, they must undergo the FDA’s drug approval process,” FDA acting associate commissioner for regulatory affairs Mike Chappell said in a statement. “The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process.”
Under its OTC drug monograph system, the FDA allows marketing of some drugs without prior agency approval. These drugs must comply with regulations that set requirements for the drugs’ labeling and formulation, as well as the uses for which they can be marketed.
The FDA said the two Bayer drugs did not meet the conditions in any OTC monograph and did not have FDA approval, making them unapproved new drugs.
Bayer launched Aspirin with Heart Advantage earlier this year. Controversy over the product’s marketing erupted when the American Herbal Products Association sent a letter to the FDA challenging the launch of the product and requesting that the agency clarify its policy on OTC products combining drugs and dietary supplements, Drug Store News reported in June. At the same time, however, the Council for Responsible Nutrition did not object to the product’s launch.