US-based based generic pharmaceutical company Ingenus Pharmaceuticals announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for its Conjugated Estrogens Tablets, USP, the first FDA-approved generic equivalent to Premarin Tablets, and is launching the product commercially.
Conjugated Estrogens Tablets, USP are offered in all FDA-approved strengths: 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg.
Indicated in the treatment of moderate to severe vasomotor symptoms due to menopause and the prevention of postmenopausal osteoporosis, the product is available to customers nationwide immediately.
Paul Dutra, Ingenus Pharmaceuticals executive vice president, said: "The availability of the first generic version of Premarin Tablets represents a significant step forward in expanding access to this important therapy."
CHMP issues positive opinion for DAWNZERA in hereditary angioedema
Merck to acquire Cidara Therapeutics in USD9.2bn deal to expand antiviral portfolio
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
Ascletis Pharma announces ASC36 and ASC35 co-formulation for clinical development
EirGenix signs second global exclusive licensing deal with Sandoz
Anixa Biosciences secures U.S. Patent strengthening breast cancer vaccine IP into mid 2040s
enGene reports 62% six-month complete response rate for detalimogene in LEGEND trial
Nurami Medical completes Phase 1 milestones in EIC-backed grant for Artifix
Avingtrans subsidiary Adaptix secures FDA clearance for 3D orthopaedic imaging system
Innate Pharma cleared by FDA to launch TELLOMAK 3 Phase 3 trial of lacutamab in CTCL
Exact Sciences secures US exclusive license to Freenome's blood-based colorectal cancer tests