Generic Premarin Approved and Launched

On Nov. 13, 2025, Ingenus Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved a generic version of Pfizer’s Premarin^® (conjugated estrogens) tablets for the treatment of menopausal symptoms, including vasomotor symptoms (hot flashes) and vaginal atrophy. The FDA originally approved Premarin tablets in 1942 and from 1972 to 1990, several competitors marketed generic tablets containing natural and synthetic estrogens until Wyeth-Ayerst (now Pfizer) challenged their bioequivalence, leading to FDA withdrawal of those generics in 1990. All FDA approved strengths, including 0.3mg, 0.45mg, 0.625mg, 0.9mg and 1.25 mg, are immediately available in the US manufactured by Novast Laboratories. They will hold competitive generic exclusivity until Apr. 15, 2026. Annual US sales are estimated at $233 million. This approval coincides with updated labeling guidelines for hormone replacement therapies, which remove broad boxed warnings for cardiovascular disease, breast cancer and probable dementia, while retaining warnings for endometrial cancer in estrogen-alone regimens. The prescribing information can be found here.

First Omnipaque Generic Approved

The FDA approved Amneal Pharmaceuticals’ iohexol injection (300mg iodine/mL) on Nov. 13, 2025, marking the first generic version of GE Healthcare’s Omnipaque^® (iohexol injection). Indicated as a radiographic contrast agent for adults and pediatric patients two weeks and older, it can be used for intrathecal, intra-arterial, intravenous (IV), oral, rectal, intra-articular and body cavity imaging procedures. The US annual sales for 12 months ending September 2025 were $652 million. Amneal expects to launch its generic iohexol injection in the first quarter of 2026. Here is the prescribing information.

MedWatch Update

Boxed Warning Removed for Hormone Replacement Therapy

The US Department of Health and Human Services (HHS) and the FDA announced the removal of broad boxed warnings from hormone replacement therapy (HRT) products for menopause on Nov. 10, 2025. The FDA’s decision – made without convening an Advisory Committee – was based on a comprehensive literature review, expert panel input and public comments. The updated labeling aims to reduce risk messaging regarding cardiovascular disease, breast cancer and dementia, while retaining warnings for endometrial cancer in estrogen-only products. Per the announcement, HRT use dropped sharply in the early 2000s after FDA boxed warnings followed a Women’s Health Initiative study linking older formulations to a slight, statistically non-significant rise in breast cancer risk among women beyond typical menopausal age and reported elevated risks of stroke and thromboembolism with late initiation. Updated labeling will emphasize evidence showing that initiating HRT within 10 years of menopause or before age 60 can reduce all-cause mortality, fractures and risks of cardiovascular disease and dementia. Prescribers are advised to individualize therapy, with systemic HRT recommended for early initiation post-menopause. See here for more information.