Mylan gets tentative go-ahead for generic Pepcid

The US Food and Drug Administration has tentatively approved Mylan'sAbbreviated New Drug Application for famotidine 20mg and 40mg tablets, the generic equivalent to Merck Research Laboratories' Pepcid, which is indicated for the long-term treatment of active duodenal ulcers and gastroesophageal reflux disease. The product will be shipped upon final FDA approval and the expiration of Merck's patent protection on April 15, said the firm. Merck launched a new formulation, Pepcid Complete (famotidine and calcium carbonate), last year to help reduce the impact of the patent expiry.