Colestipol

ANI Pharmaceuticals Announces the FDA Approval of Colestipol Hydrochloride Tablets USP

Retrieved on: 
Tuesday, April 4, 2023
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Abbreviated New Drug Application, ANI, Food and Drug Administration, Tablet, RLD, Patient, ANDA, Food, Generic drug, Colestipol

ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Colestipol Hydrochloride Tablets USP, 1 g.

Key Points: 
  • ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Colestipol Hydrochloride Tablets USP, 1 g.
    ANI’s Colestipol Hydrochloride Tablets are the generic version of the Reference Listed Drug (RLD) Colestid®.
  • The current annual U.S. market for Colestipol Hydrochloride Tablets is approximately $81.3 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • "We are pleased to expand our generics portfolio with the launch of Colestipol, bringing to market a product with a limited number of suppliers.
  • We remain committed to providing patients access to high-quality medicines,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

Intercept Announces Closing of Transaction with Advanz Pharma to Transfer Rights to Commercialize Ocaliva® for PBC Outside the U.S.

Retrieved on: 
Friday, July 1, 2022
FDA, Constipation, Warfarin, NASH, Patient, LinkedIn, Liver, Colesevelam, Adult, Hepatotoxicity, Abdominal pain, Colestipol, Theophylline, Fatty liver disease, BSEP, INR, GLOBE, CYP1A2, OCA, Population, Prothrombin time, Failure, Alkaline phosphatase, Bilirubin, Primary biliary cholangitis, Rash, Hyperlipidemia, MHRA, Jaundice, Obeticholic acid, UDCA, FXR, Bile, Intercept Pharmaceuticals, EMA, Intercept, Therapy, Autoimmune hepatitis, Ciclosporin, Arthralgia, Dizziness, Fatigue, Absorption, Survival, Nasdaq, Sleep, Ascites, ALP, Cirrhosis, Ursodeoxycholic acid, FLS, Hepatic encephalopathy, Dermatitis, Twitter, Alcoholic liver disease, PBC, Itch, Pharmaceutical industry, Vaccine, Medical imaging, Dietary supplement, Generic drug, Advanz Pharma

As a result of this transaction, Intercepts international business has been divested and its international commercial and medical infrastructure have transitioned to Advanz Pharma.

Key Points: 
  • As a result of this transaction, Intercepts international business has been divested and its international commercial and medical infrastructure have transitioned to Advanz Pharma.
  • Upfront consideration for the transaction is $405 million, subject to working capital, closing costs, France reimbursement liability and other adjustments.
  • OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC).
  • OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.