Alembic Pharma gets very last nod from USFDA by admin- Monday, October 26th, 2020 04:11:06 PM
Alembic Pharmaceuticals has acquired very last approval from the USA Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5%. The accepted ANDA is therapeutically equivalent to the reference listed drug product (RLD), Timoptic-XE Ophthalmic Gel Forming Solution, zero.25% and 0.Five%, of Bausch Health US, LLC. Timolol Maleate Ophthalmic Gel Forming Solution is indicated inside the remedy of expanded intraocular stress in patients with ocular high blood pressure or open-perspective glaucoma. Alembic has been granted a Competitive Generic Therapies (CGT) designation for this ANDA and it is eligible for 180 days of . CGT exclusivity as it is the primary permitted ANDA.
Timolol Maleate Ophthalmic Gel Forming Solution, zero.25% and zero.Five% has an estimated market size of US$ 71 million for three hundred and sixty five days ending June 2020
in keeping with IQVIA. This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Pvt Ltd.
Alembic has a cumulative overall of 134 ANDA approvals (117 very last approvals and 17 tentative approvals) from USFDA.