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相关临床试验
8
7 进行中
药物批准
48
批准总数
监管机构
3
监管机构数
成立时间
N/A
已完成
1
12.5%
尚未招募
7
87.5%
FDA
Food and Drug Administration
14
PHILIPPINES
Philippines FDA
6
NPRA
National Pharmaceutical Regulatory Agency
28
- FDC Limited has received FDA approval for its abbreviated new drug application (ANDA) for pilocarpine hydrochloride ophthalmic solution in three concentrations (1%, 2%, and 4%). - The generic ophthalmic solution is indicated for multiple conditions including reduction of elevated intraocular pressure in glaucoma patients, management of acute angle-closure glaucoma, and induction of miosis for presbyopia. - This approval allows the India-based pharmaceutical company to market the generic version in the United States, potentially expanding access to this established glaucoma and presbyopia treatment. - The approval follows recent launches of brand-name pilocarpine products including Vuity from Allergan/AbbVie and QLOSI from Orasis Pharmaceuticals for presbyopia treatment.
