Amneal Launches First Vagifem® Generic
BRIDGEWATER, N.J.–(BUSINESS WIRE)–#Vagifem–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.
All trademarks listed in this release are property of their respective
owners.
Contacts
Amneal Pharmaceuticals LLC
Jim Luce (sales)
Executive Vice
President, Sales & Marketing
M: 949.500.5756
jim@amneal.com
or
Apurva
Saraf (business development)
Vice President, Global Corporate
Development
M: 631.742.7674
apurvas@amneal.com
or
Cheryl
Lechok Communications
Cheryl Lechok (media)
President
Dir:
203.961.9280
clechok@optonline.net
