Bristol-Myers Squibb and Gilead Sciences have submitted a new drug application to the FDA for approval of a product combining the anti-HIV medications Sustiva (efavirenz), manufactured by Bristol-Myers Squibb, and Truvada (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead in a once-daily single tablet regimen. If approved by the FDA, the new single tablet regimen would be the first and only product that contains a complete highly active antiretroviral therapy regimen in a single once-daily tablet, the companies said.
Novartis announced its new drug application (NDA) for Exforge (amlodipine besylate/valsartan) was accepted for standard review by the FDA as a new treatment option for people with high blood pressure. The submission for EU approval was completed earlier in 2006.
The FDA this week issued a safety alert not to administer drugs containing promethazine hydrochloride to children younger than 2, citing seven cases of death linked to use of the antihistamine. The agency said it has also received 22 reports of severe breathing problems associated with the use of the drug—all in children younger than 2. Promethazine HC1 is sold by Wyeth as Phenergan and is available in various generic versions. The warning covers all forms of the drug, including syrups, suppositories, tablets and injectable liquids. Labels on all versions of the drug have been updated to reflect strengthened warnings, the FDA said. Promethazine hydrochloride was approved by the FDA in 1951 and is used to treat hay fever and a stuffy or runny nose due to allergies.