Teva's ProAir HFA receives expanded indication from FDA

Teva Pharmaceutical’s ProAir HFA, an albuterol sulfate inhalation solution has received an expanded indication from the U.S. Food and Drug Administration for treating bronchospasm in children suffering with reversible obstructive airway disease. Previously approved for patients above 12 years of age, ProAir HFA is now recommended for patients older than 4 years. The indication was expandedc on the basis of a 3-week long study which concluded that 2 inhalations of the solution 4 times a day treated the symptoms significantly.

FDA approves generic Camptosar in chemotherapy

Teva Pharmaceutical Industries has received FDA approval for the Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer’s chemotherapy agent, Camptosar(R) (Irinotecan Hydrochloride) Injection. Camptosar’s patent expired last month and the drug had annual sales of about $556 million in the U.S. in the twelve months ended December 31, 2007. The other companies that have received approval to launch the generic version of Pfizer’s chemotherapy agent are Actavis and APP Pharmaceuticals.