Shire has received an approvable letter from FDA for Intuniv (guanfacine) extended release tablets (previously referred to as SPD503), a nonstimulant selective alpha-2A-receptor agonist, which has been studied in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Unlike some other ADHD treatments, Intuniv, a nonstimulant, is not a controlled substance and does not have a known mechanism for potential abuse or dependence. The information requested by the FDA was not unexpected, Shire said in a statement and the drug maker is said it plans to work with the FDA to provide a full and timely response to the agency's request.
Novartis Consumer Health announced that the FDA has granted approval to its Thrive (Nicotine Polacrilex Gum USP) 2mg and Thrive (Nicotine Polacrilex Gum USP) 4mg to help smokers quit smoking in 12 weeks. The mint-flavored nicotine replacement gum will be available as an over-the-counter (OTC) product nationwide beginning in late 2007 to help smokers double their chances of kicking the habit.
The approval of Pfizer's maraviroc was dealt a blow Wednesday as the drug's maker received an approvable letter from the FDA requesting additional information on the investigational HIV compound. The FDA had been expected to approve last week. Pfizer said in a statement, “We plan to continue discussions with the FDA to address any outstanding questions and finalize the product labeling as soon as possible.” Pfizer did not elaborate on the approvable letter’s questions or issue a timetable for FDA action. Maraviroc was granted priority review status in February. Priority review status, which trims time off the standard approval time period, is usually granted to compounds deemed an advance over existing therapies by the FDA. In April, an FDA panel of outside experts recommended the agency approve maraviroc, citing a need for new HIV treatments. However, some panelists shared concerns about liver damage, heart problems and infection associated with the drug. GlaxoSmithKline stopped work on a similar CCR5 drug after it was found to cause liver problems.