Dr Reddy's Laboratories on Thursday announced that it was preparing to launch Famotidine 10 mg tablets in the US generics market.
The company had received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for the product on August 17, 2001.
Dr Reddy's will be marketing the product through California-based Leiner Health Products, a leading OTC company. Famotidine 10 mg tablets is the second product to be marketed by Leiner which is already marketing Dr Reddy's Ranitidine 75 mg tablets.
Famotidine is the generic version of Merck's Pepcid AC and is indicated for the treatment and prevention of heartburn associated with acid indigestion and a sore stomach. The product had annualised sales of over $125 million last year.
Dr Reddy's currently markets Ranitidine 75 mg tablets, Ranitidine 150 mg and 300 mg capsules, Famotidine 20 mg and 40 mg tablets, Oxaprozin 600 mg tablets and Fluoxetine 40 mg capsules in the US generics market.
The company also has two tentative ANDA approvals for Ciprofloxacin 100 mg, 250 mg, 500 mg, 750 mg tablets and Omeprazole 40 mg capsules.
Dr Reddy's became the first Indian company to get 180-day market exclusivity for a generic product in the US market when it launched the Fluoxetine 40 mg capsules on August 3, 2001.
