Renova Pharmaceuticals has launched its first three FDA-approved generic medicines in the United States: L-glutamine for oral solution, dimethyl sulfoxide irrigation 50%, and ascorbic acid injection.
The launches mark Renova’s entry into commercial sales after developing its product and regulatory pipeline. The company is based in Somerville, New Jersey, and focuses on generic medicines for the U.S. market.
Dimethyl sulfoxide, or DMSO, irrigation 50% received FDA approval with a Competitive Generic Therapy designation, the company said. The designation applies to certain generic medicines for which FDA seeks to encourage competition.
L-glutamine for oral solution, DMSO irrigation and ascorbic acid injection are the company’s first commercialized products. The announcement did not provide the reference drugs, approved indications, dosage configurations or details of the products’ market availability.
Renova said it is building a portfolio that includes sterile injectable medicines, ophthalmic products, complex generics and selected oral dosage forms. Additional products are in development or under FDA review, according to the company.
The company said it plans to grow its U.S. portfolio through internal development, partnerships and additional product opportunities.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!