CHESTNUT RIDGE, N.Y., July 29, 2015 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has begun shipping the authorized generic version of Par Specialty Pharmaceutical's Megace® ES (megestrol acetate, USP) oral suspension. Par's launch of its authorized generic product follows a competitor's introduction of the first generic version of Megace® ES. Megace® ES oral suspension is a progestin indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
The product is available in 150 mL bottles. For the first quarter of 2015, Par's net sales of Megace® ES were $4.9 million.
Important Information About Megestrol Acetate, USP, Oral Suspension
Megace® ES (megestrol acetate) oral suspension is contraindicated in patients with a history of hypersensitivity to megestrol acetate or any component of the formulation, or in patients with known or suspected pregnancy. Nursing should be discontinued. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, overt Cushing's Syndrome, and adrenal insufficiency have been reported in association with chronic megestrol acetate use. Use with caution in patients with a history of thromboembolic disease. Dose modification may be necessary for the elderly, and should be considered in these patients with compromised renal function. Megace® ES may induce vaginal bleeding in women. The most common adverse events occurring in >5% of all patients receiving 800 mg/20 mL of megestrol acetate oral suspension in the two clinical efficacy trials were nausea, diarrhea, impotence, rash, flatulence, hypertension, and asthenia. For further details, please refer to the full prescribing information at www.parpharm.com
Megace® is a registered trademark of E.R. Squibb & Sons, LLC licensed to Par Pharmaceutical, Inc.
About Par Pharmaceutical Companies, Inc.
Par is a specialty pharmaceutical company that develops, manufactures and markets safe, innovative and cost-effective pharmaceuticals that help improve patient quality of life. Par Pharmaceutical offers a line of high barrier-to-entry generic drugs, while Par Specialty Pharmaceuticals provides niche, innovative brands. Par Sterile Products develops, manufactures and markets both branded and generic aseptic injectable pharmaceuticals. For press release and other company information, visit www.parpharm.com.
SOURCE Par Pharmaceutical Companies, Inc.