Cystadrops FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 27, 2020.
FDA Approved: Yes (First approved August 19, 2020)
Brand name: Cystadrops
Generic name: cysteamine hydrochloride
Dosage form: Ophthalmic Solution
Company: Recordati Rare Diseases Inc.
Treatment for: Corneal Cystine Crystal Accumulation
Cystadrops (cysteamine hydrochloride) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.
- Cystadrops is administered by instilling one drop into each eye, 4 times a day during waking hours.
- Common adverse reactions (≥ 10%) are eye pain, vision blurred, eye irritation, ocular hyperaemia, instillation site discomfort, eye pruritus, lacrimation increased, and ocular deposits.
Development timeline for Cystadrops
|Aug 26, 2020||Approval FDA Approves Cystadrops (cysteamine) Ophthalmic Solution for the Ocular Manifestations of Cystinosis|
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