Allergan said Thursday that the U.S. FDA approved its supplemental Biologics License Application (sBLA) for Botox for the treatment younger patients with lower limb spasticity, excluding spasticity caused by cerebral palsy (CP).
Allergan’s shareholders have voted to approve to be bought by AbbVie Inc for approximately $63 billion, as more than 99 percent of the votes cast were in favor of the transaction, representing about 69% of the shares outstanding and eligible to be voted at each of the Allergan shareholder meetings held on October 14, 2019 in Dublin, Ireland.
Allergan and Molecular Partners’s Abicipar pegol DARPin therapy was accepted by FDA in the USA, and the European Medicines Agency (EMA) has validated a Marketing Authorisation Application (MAA), for patients with neovascular (wet) age-related macular degeneration (nAMD).
Allergan got U.S. Food and Drug Administration (FDA) approval for the use of Juvéderm VOLUMA XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE™ cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21.
– Phase IIIb study met all primary and secondary endpoints
with statistical significance and demonstrated that linaclotide improved
the overall abdominal symptoms of bloating, pain and discomfort in
adults with IBS-C –
Allergan and Gedeon Richter got the U.S. Food and Drug Administration approval for a supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults.
Allergan and Molecular Partners revealed Tuesday the topline safety results from MAPLE, study which enrolled 123 age-related Neovascular Macular Degeneration (nAMD) patients and evaluated the safety of abicipar produced via a modified manufacturing process, which showed lower incidence and type of IOI.
Allergan has expanded the label of Avycaz, as it got approval from the US FDA for its supplemental New Drug Application (sNDA), for treating young patients with complicated intra-abdominal infections.