Hi-Tech Pharmacal Co., Inc. a specialty pharmaceuticals company, announced that the US Food and Drug Administration, (FDA) granted final approval for the company's Abbreviated New Drug Application, (ANDA) for ranitidine syrup 15mg/mL, the generic for GlaxoSmithKline's Zantac syrup. Ranitidine syrup had sales of $21 million for the 12 months ended December 2010 according to IMS sales data. The product is indicated for the treatment of duodenal ulcers.
Hi-Tech currently has 13 products awaiting approval at the FDA, targeting brand and generic sales of approximately $1.0 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.
Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products. The Company specializes in difficult to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products.