News
Xiromed LLC Announces Approval and Launch of First-to-Market Generic Progesterone Vaginal Insert 100mg
Press Release Florham Park, NJ, September 30th, 2025 Xiromed LLC today announced the launch of Progesterone Vaginal Insert, 100 mg, generic to Endometrin®. Xiromed’s Abbreviated New Drug Application (ANDA) approval is the first generic approved by the U.S. Food and Drug Administration (FDA) with a Competitive Generic Therapy (CGT) designation and is eligible for 180-day […]
Xiromed LLC Announces Launch of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single Dose Ampules in the United States
Press Release Florham Park, NJ, September 4th, 2025 Xiromed LLC today announced the launch of Phytonadione Injectable Emulsion USP, 10mg/mL, single dose ampules. Annual market sales for Phytonadione Injectable Emulsion 10mg/mL for the twelve-month period ending July, 2025 were $19.4 million, according to IQVIA™. “The launch of Phytonadione Injectable Emulsion, USP demonstrates Xiromed’s commitment to […]
Xiromed LLC Launches Ganirelix Acetate Injection 250mcg/0.5mL Pre-Filled Syringe
Press Release Florham Park, NJ, April 8th, 2024 Xiromed LLC today announced the launch of Ganirelix Acetate Injection 250mcg/0.5mL Pre-Filled Syringe, generic to Organon Pharmaceutical’s Ganirelix Acetate Injection, the reference listed drug (RLD). Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation. According to IQVIA, a […]
Xiromed LLC Launches Guanfacine Tablets
Press Release Florham Park, NJ, April 5th, 2024 Xiromed LLC today announced the launch of Guanfacine Tablets, 1mg and 2mg strengths, generic to Tenex®. Xiromed’s product will be available in 100 count bottles. Annual sales for Tenex® and its generics for the 12-month period ending in January, 2024 were $35m, according to IQVIA, a […]
Insud Pharma successfully closes acquisition deal for Women’s Healthcare business from Viatris
Thanks to this deal the Spanish global company highlights its continuous commitment to women’s health and strengthens its presence in emerging markets The company adds two more plants to its manufacturing network Insud Pharma today announced that it has completed the transaction to acquire the Women’s Healthcare business, primarily related to oral and injectable contraceptives, […]
Xiromed LLC Announces Launch of EnilloRing® in the United States
Press Release Florham Park, NJ, October 3, 2023 Xiromed LLC today announced the launch of EnilloRing® (etonogestrel/ethinyl estradiol vaginal ring), a generic version of Nuvaring®. EnilloRing® is a contraceptive vaginal ring. “The launch of EnilloRing® is an exciting milestone in Xiromed’s journey to becoming a leading generic provider of women’s health care products in the […]
Xiromed LLC Launches Ramelteon Tablets
Press Release Florham Park, NJ, September 29th, 2023 Xiromed LLC today announced the launch of Ramelteon Tablets, 8mg, generic to Rozerem®. Xiromed’s product will be available in 30-count and 100-count bottles. Xiromed CEO Rob Spina commented, “Xiromed continues to expand its portfolio of generic pharmaceutical products with the launch of Ramelteon Tablets. We remain focused […]
Xiromed LLC Announces Launch of First-to-Market Generic Version of Balcoltra® in the U.S.
Press Release Florham Park, NJ, August 17 th , 2023 Xiromed LLC today announced that it has received approval for its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Joyeaux® (Levonorgestrel and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets USP), the first generic version of Balcoltra®. Joyeaux® is […]
Xiromed LLC Launches Betamethasone Valerate Foam, 0.12
Press Release Florham Park, NJ, August 2nd, 2023 Xiromed LLC today announced the launch of Betamethasone Valerate Foam, 0.12%, generic to Luxiq®. Annual market sales for Luxiq® and its generics for the twelve-month period ending June, 2023 were $4.4 million, according to IQVIA™. Betamethasone Valerate Foam, 0.12% is a medium potency topical corticosteroid indicated for […]