Key Developments For Hi-Tech Pharmacal Inc
Hi-Tech Pharmacal Inc (HITK.O) (Nasdaq)
Hi-Tech Pharmacal Acquires Assests Of ECR Pharmaceuticals
Hi-Tech Pharmacal announced the signing of a definitive agreement under which Hi-Tech acquired the assets of ECR Pharmaceuticals, a privately held branded specialty pharmaceutical company for $5.1 million in an all-cash transaction, which will be paid over an eight month period. Additionally, Hi-Tech may pay up to $4.0 million in performance incentives tied to future ECR product sales and profits. Under the terms of the acquisition Hi-Tech receives rights to ECR`s product line, including branded prescription products for the treatment of allergy, headache and dermatitis/poison ivy.
Hi-Tech Pharmacal Receives Final Approval For Dorzolamide Ophthalmic Solution
Hi-Tech Pharmacal announced that the U.S. Food and Drug Administration (FDA) granted final approval to the Company's Abbreviated New Drug Application (ANDA) for dorzolamide ophthalmic solution, 2%. Hi-Tech's dorzolamide ophthalmic solution is the generic for Merck's Trusopt ophthalmic solution 2%, indicated for elevated intraocular pressure in patients with ocular hypertension or open-angel glaucoma. Trusopt had sales of $45 million for the 12 months ended June 2008 according to IMS. Hi-Tech plans to launch generic dorzolamide ophthalmic solution 2% immediately.
Hi-Tech Pharmacal Files Suit To Confirm Market Exclusivity Status Regarding Dorzolamide And Timolol Ophthalmic Solution
Hi-Tech Pharmacal announced that it has filed a complaint in the U.S. District Court for the District of Columbia against the U.S. Food and Drug Administration (FDA) requesting a declaratory judgment related to Hi-Tech Pharmacal's Abbreviated New Drug Application (ANDA) for dorzolamide and timolol ophthalmic solution, the generic for Merck's Cosopt. Hi-Tech Pharmacal seeks confirmation that it is entitled to a 180-day period of market exclusivity as the first applicant to submit an ANDA to the FDA containing a paragraph IV certification challenging the validity of the brand company's patents. Hi-Tech Pharmacal's complaint also seeks issuance of an injunction preventing the FDA from granting final marketing approval to any other ANDA for 180 days after Hi-Tech Pharmacal commences commercial marketing.
Hi-Tech Pharmacal Receives FDA Approval For Dorzolamide Hydrochloride With Timolol Maleate Ophthalmic Solution
Hi-Tech Pharmacal announced that the US Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride with timolol maleate ophthalmic solution. Hi-Tech's dorzolamide hydrochloride with timolol maleate ophthalmic solution is the generic equivalent of Merck's Cosopt and is indicated for the treatment of glaucoma.
Hi-Tech Pharmacal Receives Final Approval For Ofloxacin Otic Solution
Hi-Tech Pharmacal announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for Ofloxacin otic solution, 0.3%. The Company's Ofloxacin otic solution is the generic equivalent of Daiichi's Floxin otic solution, 0.3% indicated for the treatment of bacterial infections of the ear.
