FDA warns companies using ibuprofen in OTC topical pain relievers
ROCKVILLE, Md. The Food and Drug Administration on Thursday announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter topical drug products containing the pain reliever ibuprofen.
The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed, the agency stated.
“These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” stated Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research.
Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs’ labeling, formulations, and indications. However, ibuprofen is not included in any OTC drug monograph.
Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.
The names of the products and manufacturers that received warning letters are:
- Emuprofen (Progressive Emu);
- BioEntopic 15% Ibuprofen Creme (BioCentric Laboratories);
- Ibunex Topical Ibuprofen (Core Products International);
- LoPain AF 15% Ibuprofen Creme (Geromatrix Health Products);
- IB-RELIEF (MEKT);?Profen HP (Ridge Medical Products);
- IbuPRO-10 Plus (Meditrend, doing business as Progena Professional Formulations); and
- IBU-RELIEF 12 (Wonder Laboratories).
The FDA warning letters advise the companies that they may not continue to market their products without FDA approval. The FDA is requesting a written response from the companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future.
BioNeutral Group presents lab results for antimicrobial used on swine flu
NEWARK, N.J. BioNeutral Group on Thursday announced that independent lab test results conducted at Microbiotest of Sterling, Va., demonstrated that its Ygiene Consumer Grade Antimicrobial totally eradicated the novel H1N1 virus within 20 seconds of contact.
“We are well on our way to achieving our objective to have the fastest-acting, least-expensive, longest-lasting, simple-to-use, green formulations to eliminate swine flu from home, office, schools and public gathering places,” stated Andy Kielbania, chief scientist for Bioneutral Group. “This mild formulation can come into daily contact with skin and clothing, providing added protection against H1N1 and other dangerous organisms for the general population and the broader healthcare sector, as well.”
Ygiene is one of a few antimicrobials actually tested against the specific H1N1 virus, the company stated.
The formulation will be presented to the U.S. Environmental Protection Agency for regulatory approval, the company stated.
Perrigo gears up for cough-cold season
ALLEGAN, Mich. Perrigo is steeling for a potential volatile cough-cold season this year, because even as news of the continued H1N1 pandemic dominates the American conscience, the fact is recent cough-cold seasons have been historically weak.
“The H1N1 influenza outbreak is a cause for concern for all of us,” commented Perrigo president, CEO and chairman Joe Papa to analysts. “We take this outbreak very seriously and our retailers are preparing for the flu season right now,” he said, noting that the category represents approximately 12% of Perrigo revenues.
Outside of cough/cold, however, Perrigo’s next fiscal year looks very promising, especially given an economically-driven move to private label and the better value equation of store brand, over-the-counter products. “The overall OTC consumer market was up 4% in the [fourth] quarter versus last year as national brands were essentially flat,” Papa said, discussing Perrigo’s fourth-quarter results for the fiscal year ended June 27. “Store brands gained 13% on the strength of new product launches and increased market share … the analgesic and gastrointestinal categories were up more than 4% during the quarter. National brands were relatively flat in those categories but store brands grew 9% and 20% respectively in those categories.”
Overall consumer healthcare fourth-quarter net sales increased 9% to $407 million, results that are pared against the very successful launches of omeprazole and cetirizine. “That means this is a 9% incremental growth on top of those launches last year,” commented Judy Brown, Perrigo EVP and CFO. “Approximately 7 percentage points came from both new and existing product sales growth and another 9% came inorganically from the acquisition of JB Labs, Unico, Diba and Brunel.”
Perrigo is projecting revenue growth of between 6% and 8% in the coming fiscal year. “Our plan does factor in competition in the gastrointestinal and smoking cessation category during the year,” Brown said. “We are also aware of the FDA reviews related to acetaminophen-containing products and believe the impact to our consumer healthcare business will be limited during the transition to new product lines.”
Perrigo is planning to launch as many as 20 new products in the coming year, including potential private-label competition to Schering-Plough’s laxative MiraLax (brand sales of approximately $200 million and growing 20% per year) beginning in Perrigo’s fiscal second quarter this fall.
Perrigo also plans to launch store-brand versions of Reckitt Benckiser’s cough/cold remedy Mucinex and McNeil Consumer Healthcare’s Monistat-1 this year. Annual brand sales for Mucinex are approximately $150 million, Perrigo reported.
Monistat-1 currently has $80 million in annual branded sales, Pap stated.