FDA announces extension on new labeling requirements for OTCs, supplements
ROCKVILLE, Md. The Food and Drug Administration on Friday announced that it has extended by one year the date after which it will begin enforcing new labeling requirements—that labels of over-the-counter medicines and nutritional supplements include contact information, either a complete domestic address or phone number, so that consumers can report serious adverse events associated with the use of those products.
The FDA will begin enforcing those labeling requirements Jan. 1, 2010, now.
“We believe that it is reasonable to allow an additional two-year period for firms whose labels do not yet meet the requirements … to bring their labeling into full compliance,” the agency stated in a guidance. “This period of enforcement discretion should be adequate to enable all firms to meet the new labeling requirements.”
Currently, under FDA’s “Drug Facts” regulations, the labels of OTC drug products may include a telephone number as a source to answer questions about the product, with the heading “Questions?” or “Questions or comments?”
After Jan. 1, 2010, the agency is recommending OTC and dietary supplement manufacturers spell out for consumers that the contact information is for purposes of reporting serious adverse events. “Although [the regulation] does not require the label to include anything other than a domestic address or phone number for the [manufacturer], FDA recommends that the label bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product,” the agency stated in its guidance.
Mexican product released in U.S. may prevent erectile dysfunction
SAN FRANCISCO Hispanic men between the ages of 20 and 50 are two and a half times as likely as men of other races and ethnicities to develop erectile dysfunction, according to a study published in the Archives of Internal Medicine in 2005.
A product on the market in Mexico since 2004 and recently introduced in the United States might address the problem. CRB Ventures said the product, The Sensual Tea, has a rate of effectiveness of 87.3 percent in treating erectile dysfunction and premature ejaculation and has no side effects.
“It is possible to prevent sexual problems from ever occurring,” CRB Ventures president Christian Beasley said in a statement. “The Sensual Tea overcomes low libido and sexual fatigue and enhances the pleasure and intensity of sex.”
Valeant pays $285 million for derm drug maker
ALISO VIEJO, Calif. Valeant Pharmaceuticals has agreed to buy Dow Pharmaceutical Sciences—which makes drugs to treat acne and other skin conditions, primarily for other pharmaceutical companies—for $285 million, according to several reports.
The deal, set to close in the next few weeks, considerably expands Valeant’s presence in the dermatological space.
The privately held Dow Pharmaceutical Sciences—no connection to Dow Chemical—recently received FDA approval for a new prescription topical acne medication, Acanya, which is expected to hit the market early next year and is projected to reach sales of $70 million.
Valeant also will inherit the rest of Dow’s considerable new product development pipeline, including several other drugs for treating rosacea, fungal infections and warts.
The Dow acquisition comes close on the heels of Valeant’s November purchase of Australian skin care remedy maker DermaTech Pty Ltd., for a little more than $12 million. DermaTech makes drugs for treating acne, psoriasis, warts, head lice and nits, both prescription and OTC.
Analysts are regarding the recent moves as a bit of a “turnaround story,” for the northern California-based company formerly known as ICN Pharmaceuticals, which last year reemerged as Valeant Pharmaceuticals following a considerable restructuring.