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news.Hi-Tech Pharmaca has received the US Food and Drug Administration's (FDA) tentative approval for its abbreviated new drug application (ANDA) for brimonidine tartrate with timolol maleate ophthalmic solution, the generic for Allergan’s Combigan ophthalmic solution.
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Brimonidine tartrate with timolol maleate ophthalmic solution is used for the reduction of elevated intraocular pressure.
Hi-Tech plans to launch the product after the Company receives final approval from the FDA.
The Company filed Paragraph IV certifications against the brand’s Orange Book listed patents and litigation related to the patents is ongoing.
Hi-Tech is a pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products
It is specialized to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products.
Hi-Tech, which currently has 10 products awaiting approval at the FDA, has 20 products in active development, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays.