Archive for the 'Heartburn' Category

Salix Pharma gets FDA approval for Metozolv

SalixSalix Pharmaceuticals Ltd has received the FDA approval for the marketing of a fast-dissolving drug called Metozolv intended for treating diabetic gastroparesis and heartburn. The FDA’s approval covers 5 mg and 10 mg tablets of Metozolv ODT. The drug’s main ingredient, metoclopramide, has long been used to treat the two conditions in different forms. Diabetic gastroparesis is a condition in which the stomach takes too long to clear out food.

Perrigo receives FDA approval for generic Pepcid

Perrigo LogoPerrigo Co. has received final FDA approval for its abbreviated new drug application (ANDA) for over-the-counter Famotidine chewable tablets. The drug is comparable to Pepcid Complete, produced by Johnson & Johnson and Merck Consumer Pharmaceutical and used to provide relief from heartburn associated with sour stomach and acidity. The company expects to commence shipping the product in the third quarter of 2008.

The annual retail sales for Pepcid Complete chewable tablets are estimated at about $95 million.

Ranbaxy receives provisional FDA nod for generic Nexium

Ranbaxy logoRanbaxy Laboratories has received tentative approval from the FDA to market the generic version of AstraZeneca’s Nexium (esomeprazole magnesium) drug for the treatment of heartburn and gastroesophageal reflux disease (acid reflux). Generic Nexium has been approved in the 20mg and 40mg doses. The company has FTF (first to file) status on the drug, which potentially provides it with marketing exclusivity for 180 days after it receives final approval from the regulator.