Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

FDA Okays Acella’s ANDA for Bioequivalent of Vituz Oral Solution

By Acella Pharmaceuticals, LLC | July 28, 2017

Acella Pharmaceuticals, LLC, announces approval of generic to Vituz oral solution.

Acella Pharmaceuticals, LLC, a U.S. developer of specialty pharmaceuticals across several therapeutic categories, announced the Food and Drug Administration’s approval of the company’s abbreviated new drug application (ANDA) for a Hydrocodone Bitartrate and Chlorpheniramine Maleate Oral Solution 5 mg/4 mg per 5 mL as a bioequivalent product to Vituz Oral Solution.

This combination medicine is indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. The incidence of the common cold exceeds one billion cases in the United States each year. A majority of the population is likely to have more colds than any other type of illness. Colds can occur at any time of the year, but they are most common in the winter or rainy seasons.1-3

“Acella continues to actualize new product launch opportunities that align with our strategic mission to provide optimal healthcare support for the medical community and their patient population,” said Harold A. Deas, Jr., CEO for Acella Pharmaceuticals.
______________________________________________________

References:
 
1 Turner RB. The common cold. In: Goldman L, Schafer AI, eds. Goldman’s Cecil Medicine. 24th ed. Philadelphia, PA: Saunders Elsevier; 2011:chap 369.
 
2 Fashner J, Ericson K, Werner S. Treatment of the common cold in children and adults. Am Fam Physician. 2012;86(2):153-159. 

3 Singh M, Das RR. Zinc for the common cold. Cochrane Database of Systematic Reviews. 2011, Issue 2. Art. No.: CD001364.

(Source: PR Newswire)

Related Articles Read More >

FDA logo
Ultra Supplement announces recall for undeclared tadalafil
analyzing medical sample
Expert answers to nitrosamine impurity questions
Cardinal Health
Cardinal Health announces $124M settlement of investors’ opioid suit
FDA logo
FDA warns four companies over selling honey tainted with prescription drugs

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards