Jubilant's Generic Loperamide Hydrochloride Receives Approval in the U.S.
Rubicon's Generic nLoperamide Hydrochloride Acetate Receives Approval in the U.S.
Granules's Generic Loperamide Hydrochloride, Simethicone Receives Approval in the U.S.
Marksans Pharma yesterday said its subsidiary has received market nauthorisation from the UK health regulator for its anti-diarrhoea nmedication Loperamide capsules. The UK MHRA has granted market nauthorisation to the company’s wholly-owned subsidiary Relonchem for nLoperamide hard capsules (2mg), Marksans Pharma said in a regulatory nfiling.
Bionpharma`s Generic Loperamide Hydrochloride Receives Approval in US
Edenbridge Pharma`s Generic Loperamide HCL Receives Approval in US
Bionpharma`s Generic Loperamide HCl & Simethicone Receives Approval in the US
Hetero Labs Ltd`s Generic Loperamide Hydrochloride; Simethicone Receives Approval In US
Guardian Drug`s Generic Loperamide HCl;Simethicone Receives Approval in US
Puma Biotechnology, Inc. (NASDAQ: PBYI) announced that the U.S. Food and Drug Administration (FDA) has approved a labeling supplement for NERLYNX® (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. With the approval of the labeling supplement, the label now includes safety information based on interim results from Puma’s Phase II CONTROL Trial, a study evaluating antidiarrheal prophylaxis or dose escalation in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 or higher diarrhea. Interim data from the trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.