Just Announced and Launched August 2017

August 5, 2017 at 12:01 am

FDA Approval of QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation Aerosol
Teva announced that the U.S. Food and Drug Administration (FDA) has approved QVAR® RediHaler™ (beclomethasone dipropionate HFA) inhalation aerosol for the maintenance treatment of asthma as a prophylactic therapy in patients four years of age and older. QVAR® RediHaler™ is not indicated for the relief of acute bronchospasm. It differs from conventional metered-dose inhalers (MDIs) as it delivers medication via a breath-actuated MDI, eliminating the need for hand-breath coordination during inhalation. QVAR® RediHaler™ administers the same active drug ingredient found in QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol, with a different mode of delivery.

Tafinlar® and Mekinist® FDA Approved for Lung Cancers With BRAF Mutations
The U.S. Food and Drug Administration (FDA) recently approved the combination of dabrafenib (Tafinlar®) and trametinib (Mekinist®)  ̶  both owned by Novartis  ̶  for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) that has an alteration in the BRAV gene called the V600E mutation. Dabrafenib and trametinib block different growth-promoting signals in the MAPK pathway that are activated by the V600E BRAF mutation ̶  dabrafenib inhibits the BRAF protein, whereas trametinib is a MEK inhibitor. This is the first approval specifically for patients with BRAF V600E mutation-positive metastatic NSCLC.

FDA Approves KALYDECO® for Cystic Fibrosis With Certain Residual Function Mutations
Vertex Pharmaceuticals Incorporated recently announced that the U.S. Food and Drug Administration (FDA) has approved KALYDECO® (ivacaftor) for use in more than 600 people with cystic fibrosis (CF) ages 2 and older who have one of five residual function mutations that result in a splicing defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. This approval was based on Phase 3 clinical data for KALYDECO® in these mutations, and follows the FDA’s approval of KALYDECO in May 2017 for 23 other residual function mutations, which was based on analyses of in vitro data. Both approvals are supported by more than five years of real-world clinical experience that demonstrate KALYDECO’s established safety and efficacy profile.


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