H3 PHARMA GETS APPROVABLE LETTER FOR ESOPHAGEAL BLEEDING DRUG

The FDA has issued an approvable letter for H3 Pharma's Sanvar, a drug for the treatment of acute esophageal variceal bleeding.

In the approvable letter sent to H3, the FDA requests the company submit additional supportive efficacy data and additional manufacturing information on Sanvar (vapreotide). H3 said it intends to address the FDA's requests in the first quarter of this year.