Allergan Receives Complete Response Letter from FDA for Prior Approval Supplement for Restasis 0.05% Multi-Dose Preservative-Free bottle
FDA requested additional CMC information for the Multi-Dose Preservative-Free bottle.
Allergan has received a Complete Response Letter from the FDA for its Prior Approval Supplement (PAS) for Restasis (cyclosporine ophthalmic emulsion) 0.05%, Multi-Dose Preservative-Free (MDPF) presentation.
The FDA requested additional CMC information for the Multi-Dose Preservative-Free (MDPF) bottle, a first of its kind container with patented uni-directional valve and air filter technology. Allergan is compiling the data requested and will respond to the FDA in a timely manner. In the absence of additional data requests from the FDA, Allergan does not anticipate a significant impact to previously communicated timelines of the potential approval of the MDPF bottle.
Restasis, approved by the FDA in 2002, is the only eye drop that helps increase the eyes' natural ability to produce tears, which may be reduced by inflammation due to chronic dry eye disease. Restasis did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.
Related News
-
News Pharmaceutical Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain.
-
News Merck KGaA to buy US biotech SpringWorks for US$3.9 billion
The German multinational pharmaceutical company Merck KGaA have signed a deal to buy US biotech company SpringWorks Therapeutics at an equity value of US$3.9 billion in a move to add rare cancer therapeutics to their pipelines.
-
News Cassava Sciences halts Alzheimer's drug trial after limited progress
Cassava Sciences have drawn a close to their investigations and development of the drug simufilam, which they intended to be used for the treatment of Alzheimer’s disease.
-
News US FDA adds haemodialysis bloodlines to devices shortage list
On March 14, 2025, the US FDA published an open letter to healthcare providers citing continuing supply disruptions of haemodialysis bloodlines, an essential component of dialysis machines.
-
News Vertex Pharmaceuticals stock jumps as FDA approves non-opioid painkiller
UK-based Vertex Pharmaceuticals saw their stock shares soar as the US FDA signed off on the non-opioid painkiller Journavx, also known as suzetrigine, for patients with moderate to severe acute pain, caused by surgery, accidents, or injuries.
-
News Lessons from CPHI Milan 2024: Sunny Intervals for Pharma Manufacturing?
As the 2024 CPHI conference wrapped up in Milan, we caught up with L.E.K. Consulting – a global strategy consulting firm with deep expertise in pharma manufacturing – to discuss evolving market perspectives and business outlook. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement.