FDA grants tentative approval for Hi-Tech Pharmacal's generic Combigan ANDA

Apr 8 2011

Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK), a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted tentative approval for the Company's Abbreviated New Drug Application, (ANDA) for brimonidine tartrate with timolol maleate ophthalmic solution, the generic for Allergan's Combigan® ophthalmic solution which had sales of $108 million for the 12 months ended December 2010 according to IMS sales data. The product is indicated for the reduction of elevated intraocular pressure. The Company filed Paragraph IV certifications against the brand's Orange Book listed patents and litigation related to the patents is ongoing. Hi-Tech plans to launch the product after the Company receives final approval from the FDA.

Hi-Tech currently has 10 products awaiting approval at the FDA, targeting brand and generic sales of approximately $0.9 billion. In addition, Hi-Tech has 20 products in active development targeting brand sales of over $3 billion, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays.

SOURCE Hi-Tech Pharmacal Co., Inc.