Taro receives final FDA approval for seizure treatment
HAWTHORNE, N.Y. Taro Pharmaceutical Industries reported Friday that it received final approval from the Food and Drug Administration for its abbreviated new drug application for carbamazepine extended-release tablets.
Taro’s carbamazepine extended-release tablets have been approved in 100-mg, 200-mg and 400-mg strengths. They are bioequivalent to Novartis’ Tegretol-XR Tablets, a prescription pharmaceutical product used for treating seizures. According to industry sources, Tegretol-XR Tablets had annual U.S. sales in 2008 of approximately $100 million.
The FDA has informed the company that it was the first ANDA applicant to submit a substantially complete ANDA for carbamazepine extended-release tablets 100-mg with a paragraph IV certification, and that no other applicant is at present eligible for approval.
The FDA also has advised Taro that it will not make a formal determination of Taro’s eligibility for 180-day generic drug exclusivity for its carbamazepine extended-release tablets 100-mg, unless another applicant becomes eligible for approval within 180 days after Taro begins commercial marketing.
Astellas Pharma introduces new formulation of Vaprisol
DEERFIELD, Ill. Astellas Pharma US announced this week the introduction of a new formulation of a drug for treating hyponatremia.
The Tokyo-based drug maker introduced Vaprisol (conivaptan hydrochloride injection) Premixed in 5% Dextrose, a new premixed formulation. The Food and Drug Administration originally approved the drug in October.
“It is imperative to promptly address hyponatremia in emergency and hospital settings,” Georgetown University medicine and physiology professor Joseph Verbalis said in a statement. “Vaprisol Premixed in 5% Dextrose is a convenient option for quickly preparing treatment for hyponatremia patients.”
Hyponatremia is a potentially life-threatening condition that occurs when the body’s blood sodium level falls significantly below normal. It is present in about 28% of patients upon admission into acute hospital care, and another 14% acquire it while in acute care. It can result in swelling of the brain, respiratory arrest, catastrophic brain damage and death.
Diabetes drug makers experience stock jump
NEW YORK Shares of two large drug makers focused on diabetes increased Wednesday afternoon despite declines in the drug industry as a whole, according to published reports.
The Amex Pharmaceutical Index and Amex Biotechnology Index fell, while the Dow Jones Industrial Average increased after a fall earlier in the day.
Meanwhile, however, shares of Danish drug maker Novo Nordisk and San Diego-based drug maker Amylin Pharmaceuticals increased respectively by 4%, to $49.95, and 3%, to $12.12.
Amylin had released a study earlier in the week showing that a long-acting formulation of the diabetes drug Byetta (exenatide) that has not yet been launched outperformed Merck & Co.’s Januvia (sitagliptin) and Takeda’s Actos (pioglitazone hydrochloride) in patients with Type 2 diabetes.