DID - June 11, 2007 Issue

Vol. 6 No. 114

Allergan Cited for ‘Misleading’ Ad

Allergan’s journal ad for its ketorolac tromethamine ophthalmic solution Acular LS “is false or misleading” and suggests that the product “is effective for an entirely new use,” according to a warning letter from the FDA’s Division of Drug Marketing, Advertising and Communications.

The warning letter, sent May 25 to Allergan President and CEO David Pyott and posted to the agency’s website recently, states that the ad misbrands Acular LS because it “broadens the indication, presents unsubstantiated superiority claims and omits important risk information.”

The ad presents data intended to show a favorable result in a study of patients undergoing phacoemulsification who received either Acular LS or Nevanac (nepafenac ophthalmic suspension), the agency said. However, “Acular LS is not approved for any use in patients undergoing phacoemulsification. … The inclusion below these statements of the approved indication for Acular LS does not mitigate this misleading presentation,” the warning letter said.

Moreover, the data presented “do not constitute substantial evidence or substantial clinical experience supporting use in patients undergoing phacoemulsification,” the warning letter said.

The FDA also cited the company for the advertisements:

  • Implying that Acular LS is effective for treating inflammation, when this is not supported by substantial evidence or substantial clinical experience;
  • Implying that Acular LS is safe and effective when used before surgery, when this is not supported by substantial evidence or substantial clinical experience, and the product is only approved for use following surgery;
  • Misleadingly implying that Acular LS is approved for use in cataract surgery, as Nevanac is, and “misleadingly suggest[ing] that Acular LS is superior to Nevanac for use in phacoemulsification;” and
  • Failing to communicate several important risks associated with the use of Acular LS.

The FDA asked Allergan to immediately cease disseminating the ad and to submit a written response on or before June 11 stating whether it intends to comply with this request and listing all violative promotional materials for Acular LS that are the same as or similar to the ad cited.

The company was also requested to detail a plan to discontinue the use of misleading ads, as well as “to disseminate truthful, nonmisleading and complete corrective messages … to the audience(s) that received the violative promotional materials.”

“Allergan is committed to supporting the needs of eye care professionals and patients and providing balanced and accurate information about our products. We are working with the FDA to address the details provided in the letter,” Heather Katt, Allergan’s senior manager for corporate communications, told DID.

The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6376c.htm. — Martin Gidron


Lawmakers, J&J Address Drug-Resistant Tuberculosis

Sens. Sherrod Brown (D-Ohio), Kay Bailey Hutchison (R-Texas) and Edward Kennedy (D-Mass.) recently introduced legislation to expand tuberculosis (TB) research in the U.S. to find new diagnostic tools and new treatments.

All currently available therapies are ineffective against “extremely drug-resistant” tuberculosis, known as XDR-TB.

The “Comprehensive Tuberculosis Elimination Act of 2007” would give the Centers for Disease Control and Prevention (CDC) the authority to respond to international outbreaks of XDR-TB and increase funds for the CDC’s National Program for the Elimination of Tuberculosis.

In addition, the bill would increase TB research at the CDC and the NIH for new diagnostic and treatment tools, vaccines, at-risk populations, drugs and effective public health interventions. The legislation would also expand the CDC’s efforts to prevent, detect and treat TB, particularly in groups with high infection rates such as African-Americans and Asian-Americans, the lawmakers said.

There are currently 49 reported cases of XDR-TB in the U.S., the lawmakers added. 

The move may come as good news to Johnson & Johnson (J&J), which is working on a new antibiotic against TB that uses the first new mechanism to treat the disease in 40 years, the company said. The company recently started a mid-stage trial of the drug, called TMC207, in people with drug-resistant TB in South Africa, J&J announced.

Although the incidence of TB has been increasing worldwide in the past several years, no TB-specific drugs have been discovered in 40 years, J&J researchers said in a 2004 article published in Science. TMC207 inhibits growth of drug-sensitive and drug-resistant TB bacteria, the article said.

Kennedy and Sen. Mike Enzi (R-Wyo.) also recently sent a letter to CDC Director Julie Gerberding asking for information on current quarantine laws and the federal government’s ability to coordinate a response in case of an infectious disease outbreak. 

Approximately 1.6 million people worldwide die from TB each year, according to the World Health Organization. — Emily Ethridge


Perrigo Prevails in Pepcid Complete Patent Suit

A court has ruled in favor of Perrigo in a patent infringement suit over Pepcid Complete, the company announced.

Johnson & Johnson’s McNeil unit and Merck had sued Perrigo for infringing on a patent related to the formulation of Pepcid Complete (famotidine/calcium carbonate/magnesium hydroxide). But the U.S. District Court for the Southern District of New York ruled last week that the patent is invalid, Perrigo said.

Following final FDA approval, Perrigo will begin marketing its generic version of the OTC drug under store brand labels in 2008. The company already markets a generic version of Maximum Strength Pepcid AC 20-mg tablets.

Pepcid Complete, which is indicated for the relief from acid indigestion, has annual retail sales of approximately $90 million, according to Perrigo. The company said it expects to have 180-day marketing exclusivity for being the first company to successfully challenge the Pepcid Complete patent.

Perrigo is the largest manufacturer of OTC pharmaceutical products for the store brand market, according to the company. — Breda Lund


Eli Lilly Appealing German and Canadian Approval of Generic Zyprexa

Eli Lilly said it will appeal recent rulings by the Canadian Federal Court and the German Patent Court that could result in the entry of generic olanzapine Zyprexa into the Canadian and German markets. The company called the rulings “deeply flawed” and inconsistent with facts and legal principles, and said it would seek damages in its appeals.

“These decisions, if not overturned, undermine intellectual property protection in Canada and Germany and erode the incentives of pharmaceutical and biotech companies to make the high-risk investments necessary to discover and develop breakthrough medicines,” Eli Lilly Senior Vice President and General Counsel Robert Armitage said, adding that the company will seek to protect its Canadian and German patents for Zyprexa (olanzapine) until 2011, when the U.S. patent for the drug expires.

The company said it does not expect the court rulings to have a material impact on its earnings. In the first quarter of 2007, the antipsychotic was Eli Lilly’s best-selling drug, bringing in $1.108 billion, 10 percent more than in the first quarter of 2006. On the down side, the company has said that it could end up spending as much as $500 million to settle most of the remaining product liability claims over the drug (DID, Jan. 5). — Martin Gidron


Generic Drug Approvals

FDA Tentatively Approves Generic Risperdal

Barr announced last week that its Pliva subsidiary received tentative FDA approval for a generic version of Janssen Pharmaceutica’s Risperdal. Barr said the pediatric-exclusivity period for the schitzophrenia drug is set to expire in June 2008, which is when it could win final approval.

The company filed for approval of 0.25-, 0.5-, 1-, 2-, 3- and 4-mg generic Risperdal (risperidone) tablets, which had sales of approximately $2.5 billion during the 12-month period that ended March 31, Barr said.

Generic Zyrtec Gets Tentative Approval

Caraco has reported that the FDA tentatively approved its abbreviated new drug application for generic Zyrtec (cetirizine HCl) 5- and 10-mg tablets. The company said it expects to receive final approval Dec. 25 when Pfizer’s patent expires. The antihistimine had U.S. sales of roughly $1.21 billion in 2006, Caraco added.

Mylan Touts Generic Paxil Nod From FDA

The FDA has granted Mylan Pharmaceuticals tentative approval to market generic Paxil CR (paroxetine HCl) tablets, 12.5- and 25-mg, the company announced. Mylan is eligible to receive final approval June 29 when GlaxoSmithKline’s pediatric-exclusivity period for the extended-release depression drug expires. Paxil CR 12.5- and 25-mg tablets had U.S. sales of approximately $307 million during the 12-month period that ended March 31, Mylan said.

The company has also received final approval for generic azithromycin 250- and 500-mg tablets. The product is a generic equivalent to Pfizer’s Zithromax. Brand and generic versions of the antibiotic in the same strengths had U.S. sales of roughly $886 million during the 12-month period that ended March 31, according to Mylan.

Good News for Wockhardt’s Generic Lamisil

Wockhardt announced it won tentative approval for generic Lamisil (terbinafine HCl) tablets. The U.S. market for the nail infection drug is worth approximately $680 million, the company said. Novartis’ patent on the product expires June 29, which is when Wockhardt plans to begin marketing its product. — Breda Lund

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