Lupin gets FDA approval for generic Femhrt tablets

Drug major Lupin has received US health regulator’s approval to market Fyavolv tablets, used to treat postmenopausal osteoporosis, in the American market. The company has received received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets. The company’s product is the generic equivalent of Warner Chilcott’s Femhrt tablets, which are indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis. The Mumbai-based firm has launched eight products in the US this fiscal and received approvals for 19 from the FDA.

What is Menopause?

  • Menopause is defined as the point in time when menstrual cycles permanently cease due to the natural depletion of ovarian oocytes from aging.
  • The diagnosis is typically made retrospectively after the woman has missed menses for 12 consecutive months.
  • It marks the permanent end of fertility and the average age of menopause is 51 years.
  • The menopause is a normal part of life – it is a milestone, just like puberty – it is not a disease or a condition..

What is Osteoporosis?

  • Osteoporosis causes bones to become weak and brittle — so brittle that a fall or even mild stresses like bending over or coughing can cause a fracture.
  • Osteoporosis-related fractures most commonly occur in the hip, wrist or spine.
  • Bone mass (bone density) decreases after 35 years of age, and bone loss occurs more rapidly in women after menopause.
  • Medications, healthy diet and weight-bearing exercise can help prevent bone loss or strengthen already weak bones.