Oct 19, 2016

Amneal Launches First Vagifem Generic

Amneal Pharmaceuticals LLC (“Amneal”) announced that its newest women’s health product, Yuvafem® (estradiol vaginal inserts, USP) 10 mcg, began shipping on October 17th to distributors, wholesalers and directly to the trade.

This first-to-market generic equivalent for Vagifem® delivers the same low dose of vaginal estrogen as the brand in a preloaded, single-use, disposable applicator. The Amneal product is packaged in 8- and 18-count sizes to provide appropriate quantities for both new and maintenance prescriptions.

Prior to approving the Amneal ANDA for Yuvafem®, FDA required a clinical endpoint study, which the company successfully completed. Amneal R&D efforts are dedicated to making these types of complex medicines more affordable and accessible to patients by bringing the generic equivalent to market.

“Patients and healthcare providers have been eager to see a generic for this unique dosage-form in order to benefit from the cost savings such multi-source products can deliver,” said Chirag Patel, Amneal co-CEO and chairman. “As a company, we are not only pleased to be able to offer a potentially more affordable option in this therapeutic category, but to add to our rapidly-growing portfolio of oral contraceptives and hormone replacement therapies in such a significant way.”

Annual U.S. sales of Vagifem® were $423 million, according to July 2016 IMS market data.

Click here for full prescribing information for Yuvafem®.

About Amneal
Amneal Pharmaceuticals LLC, a privately-held company, headquartered in Bridgewater, New Jersey, is one of the largest and fastest growing generics pharmaceutical manufacturers in the United States. Founded in 2002, Amneal now has more than 4,000 employees in its operations in North America, Asia, Australia and Europe, working together to bring high-quality affordable medicines to patients worldwide. Amneal has significantly expanded its portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas. For more information, visit www.amneal.com.
 

CONTACTS:
Jim Luce (sales)
Executive Vice President, Sales & Marketing
M: 949.500.5756
jim@amneal.com

Apurva Saraf
Vice President, Global Corporate Development
M: 631.742.7674
apurvas@amneal.com

Cheryl Lechok (media)
President - Cheryl Lechok Communications
Dir: 203-961-9280
clechok@optonline.net

Market Buzz

Jun 03, 2019 PrimeCare® Integrates MedTek21® to Offer Facility-based Genomic Testing
May 22, 2019 Letco Med Announces the Launch of a New Industry-Leading Website and E-Commerce ...
May 17, 2019 MEDISCA Granted Planetary Mixing Patent and Exclusive Distribution Agreement
May 02, 2019 Transaction Data Systems (TDS) Delivers Smarter Approach to Claim Reconciliation
Apr 22, 2019 Visante healthcare consulting firm announces Judi Jacobi, PharmD, to join consul...
Apr 17, 2019 As an aging population demands more efficient pharmacy solutions, the founder of...
Apr 17, 2019 Adam Wallace Named Chief Technology Officer at Transaction Data Systems (TDS)
Apr 15, 2019 PharmaLink to Exhibit at 2019 Asembia Specialty Pharmacy Summit
Apr 04, 2019 Transaction Data Systems (TDS) Announces Acquisition of Pharm Assess, Inc.
Apr 01, 2019 Chad Collins Named President of Akro-Mils and Jamco Products
Mar 22, 2019 Tutela Welcomes Octapharma Plasma
Mar 18, 2019 Verity Solutions Recognized as Category Leader for 340B Management Systems in 20...
Mar 07, 2019 Stormont Vail Health Partners with Omnicell to Enhance Medication Management Str...
Mar 06, 2019 Rebranding Focuses ALG Mission - Combining Our Best to Bring You Our Best
Mar 04, 2019 RXinsider Celebrates 20 Years, 1999 - 2019
Feb 28, 2019 Lupin launches Generic Ranolazine ER Tablets in U.S.
Feb 18, 2019 QS/1® Offers Compliance Packaging Label Solution
Feb 15, 2019 QS/1 Partnership Offers Compliant Patient Communications
Feb 14, 2019 RXinsider is Proud to Welcome our Newest Partners!
Feb 12, 2019 Albertsons Companies Pharmacies Adopt TemperPack's ClimaCell™ Packaging
Feb 07, 2019 Fagron Launches New Brand Identity and Purpose
Feb 07, 2019 Medicine-On-Time has come together with Clinical Support Services, a leader in M...
Feb 04, 2019 Letco Med and Ananda Professional Partner to Bring CBD and Education to Compound...
Jan 30, 2019 Texas Children’s Hospital Expands Partnership with Omnicell
Jan 16, 2019 Helmer Scientific Launches the First Professional Medical-grade Refrigerators
Jan 15, 2019 The Compliance Team™ celebrates 25 years of accreditation transformation
Jan 11, 2019 CORE Higher Education Group partners with Pharmacists Mutual
Jan 10, 2019 SCA Pharma Awarded National Outsourced I.V. Admixture Services Agreement with Pr...
Jan 08, 2019 Tutela Welcomes the Center for Organ Recovery and Education
Dec 13, 2018 PharmaLink Launches Updated Website

RXinsider Product Overview Videos