The United States Food and Drug Administration (FDA) has approved three drugs for non-prescription, or over-the-counter use via a process called a prescription (Rx)-to-OTC switch, it was reported on Friday.
The FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) intended for the temporary relief of arthritis pain; Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) intended for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander; and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for non-prescription use.
The FDA granted the approval of non-prescription Voltaren Arthritis Pain to GlaxoSmithKline plc. Approvals of non-prescription Pataday Twice Daily Relief and Pataday Once Daily Relief was granted to Alcon.
The three products will be marketed in the United States as non-prescription drugs and will no longer be offered as prescription drugs.
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion