Cipla has won US Food and Drug Administration approval for the first generic version of Merck & Co’s Proventil (albuterol sulfate) HFA inhalation aerosol, marking a significant win for the firm’s burgeoning respiratory portfolio and offering of complex, limited-competition generics in the US.
Cipla Granted Approval For First US Proventil Rival
Indian Firm Says Albuterol Shipments Will Be ‘Staggered’
Shortly after wrapping up a Phase III trial for its proposed generic Advair Diskus product in the US, Cipla has won FDA approval for the first generic Proventil HFA product, as it continues to build up steam in the US respiratory market.
More from Products
• By
Doubling down on previously shared data from the firm’s STELARIS trial, Teva has reported further findings from a survey featuring subjects and professionals involved in the Phase III study for its proposed long-acting olanzapine injectable.
• By
Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
• By
Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.
• By
The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
More from Generics Bulletin
• By
Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.
• By
The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
• By
The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.