2008 immunization schedules released with updated flu, meningitis recommendations
ATLANTA Updated immunization recommendations for childhood influenza and adolescent meningococcal vaccinations are included in the 2008 Childhood and Adolescent Immunization Schedules that was released jointly Friday by the Centers for Disease Control and Prevention, the American Academy of Pediatrics and the American Academy of Family Physicians.
“Although we can now protect more children against more vaccine-preventable diseases than ever before, the immunization schedules can be confusing for parents and physicians,” noted Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at CDC. “The updates to this year’s schedule help clarify our vaccination recommendations and, therefore, should make it easier for parents to protect their children against potentially serious diseases.”
The childhood schedule expands the recommendation for the nasal spray influenza vaccine, FluMist, to include children from 2 to 4 years of age who don’t have a history of asthma or wheezing. The vaccine, which contains a weakened form of the live virus and is sprayed in the nose, had previously been limited to healthy children 5 years of age and older and healthy adults up to age 50.
“We know that vaccinating children protects them against flu,” Schuchat. “This recommendation gives parents another choice when vaccinating their children.”
The new schedule also clarifies and updates recommendations for use of pneumococcal vaccine. Healthy children 24 through 59 months of age who are incompletely vaccinated should receive one dose of pneumococcal conjugate vaccine (PCV4). Children age two and older with underlying medical conditions should receive pneumococcal polysaccharide vaccine (PPV).
Taro settles patent suit, launches generic Trileptal
HAWTHORNE Taro announced Wednesday that it has settled a patent lawsuit with Novartis and will launch oxcarbazepine tablets, the generic version of Novartis’ Trileptal. Oxcarbazepine tablets are indicated to treat seizures.
The litigation with Novartis centered on Taro’s Paragraph IV certification challenging Novartis’ patent protection on Trileptal. On Nov. 15, 2007, Taro received Food and Drug Administration approval for its abbreviated new drug application for oxcarbazepine tablets in 150 mg, 300 mg and 600 mg strengths, but the company waited to launch the drug until the lawsuit was settled.
According to Taro, Trileptal currently has annual U.S. sales of approximately $700 million.
Sciele to launch six medications in 2008
ATLANTA In addition to Sciele’s announcement last week, reported in Drug Store News, that it will launch its new Sular formulation during the first quarter of 2008, the company also announced plans to launch five other drugs this year:
- two new dosages of fenofibrate for the treatment of mixed dyslipidemia
- Prandin for Type 2 diabetes
- PrandiMet for Type 2 diabetes (pending FDA approval)
- a head lice asphyxiation product (pending FDA approval)
- a women’s health product
Sciele reaffirmed its full-year guidance at the JPMorgan 26th Annual Health Care Conference yesterday. As previously announced, full-year 2007 revenue is expected to range between $375 million and $385 million. The company expects full-year 2008 revenues to range from $440 million to $455 million.