Teva announces FDA acceptance of sNDA filing for pediatric indication of QNASL Teva Pharmaceuticals Industries announced that the U.S. FDA has accepted for review the company’s supplemental new drug application for a lower dose QNASL Nasal Aerosol for the treatment of seasonal and perennial allergic rhinitis in children 4-11 years of age. QNASL is a waterless intranasal corticosteroid spray currently available for the treatment of nasal symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients 12 years of age and older. The sNDA filing includes data from three double-blind, placebo-controlled studies that evaluated the safety and efficacy of QNASL in children with allergic rhinitis. The data demonstrated that once-daily treatment with QNASL provided significant nasal allergy symptom relief in pediatric subjects with SAR and PAR when compared with placebo. In all three studies the safety profile of QNASL was similar to that of placebo and adverse events were consistent with those seen in previous clinical studies.
Senate Health, Education, Labor & Pensions Committee to hold a hearing The Subcommittee on Primary Health and Aging holds a hearing entitled, "Why Are Some Generic Drugs Skyrocketing In Price?" with President & CEO Vigodman of Teva Pharmaceutical and President & CEO Bedrosian of Lannett Company on November 20 at 1 pm. Webcast Link
Teva patent victory over Warner Chilcott, Roche affirmed The U.S. Court of Appeals for the Federal Circuit ruled that a district court was correct to grant summary judgment to Teva (TEVA) in a patent dispute with Warner Chilcott and Roche (RHHBY) over patents related to osteoporosis drug risedronate.
Teva calls active on renewed takeover chatter Teva November 57 and 58 calls are active on total call volume of 21K contracts (2K puts) following renewed takeover chatter. November call option implied volatility is at 18, December is at 19; compared to its 26-week average of 24 according to Track Data. Active call volume suggests traders taking positions for upside price movement.