DULUTH, Ga., July 20, 2023 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved the newest innovation from the trusted NexGard® Brand of Products — NexGard® PLUS (afoxolaner, moxidectin and pyrantel chewable tablets) — a monthly beef-flavored soft chew that protects dogs from fleas, ticks, heartworm disease, roundworms and hookworms. By combining internal and external parasite protection in a tasty, beef-flavored soft chew, NexGard® PLUS helps make monthly compliance easy and enjoyable for pets and pet owners.
DURHAM, N.C., Oct. 25, 2018 /PRNewswire/ -- Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced today its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit Australian biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries. MDGH recently received U.S. Food and Drug Administration (FDA) approval of moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis).
PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence services, today celebrated an important milestone for its public health drug development and treatment consulting portfolio. Certara was engaged by Medicines Development for Global Health (MDGH) to be a key part of its integrated drug development team to gain US Food and Drug Administration (FDA) approval for moxidectin, an 8 mg oral treatment for river blindness (onchocerciasis) in patients aged 12 years and older.
Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) have announced that the United States (U.S.) Food and Drug Administration (FDA) approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older. The FDA has also awarded MDGH a priority review voucher (PRV).
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Bravecto Plus (fluralaner/moxidectin), from Intervet International B.V., a new combination product for the treatment of tick and flea infestations and nematodes in cats.
Once completed, the deal would include the transfer of CYDECTIN Pour-On, CYDECTIN Injectable and CYDECTIN Oral Drench. These endectocides with the active ingredient moxidectin offer persistent killing of internal parasites at multiple stages, including the most economically devastating parasite, Ostertagia ostertagi (brown stomach worm) and controls external parasites including lice, grubs and psoroptic mange mites on beef and dairy cattle.