Duramed Pharmaceuticals, Inc. has recently announced the two new USFDA approvals given to ENJUVIA™ (synthetic conjugated estrogens, B) product:
- supplemental New Drug Application (sNDA) for 0.9 mg tablet strength, which will be added to the Company's existing ENJUVIA product line that includes the 0.3 mg, 0.45 mg, 0.625 mg, and 1.25 mg tablet dosage strengths.
ENJUVIA™ is also the first and only oral estrogen that has been approved by FDA to treat moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause.
ENJUVIA™, a plant-derived formulation, contains a blend of 10 synthetic estrogenic substances including delta 8,9 -dehydroesterone sulfate (DHES) which utilizes a unique delivery system, consisting of Surelease® technology with a cellulose-based polymer tablet design, to provide slow release of estrogens over several hours.
Duramed Pharmaceuticals, Inc. is a subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL).
Find more details from the press release.
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