Treats anorexia, cachexia, or an unexplained significant weight loss. ANDA 203139, held by Twi Pharms. Megestrol Acetate.
As of Nov 15, 2026, ANDA 203139 (Megestrol Acetate), held by Twi Pharms, was first approved by FDA on Aug 27, 2014, with 2 approved supplements and 0 published complete response letters.
Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Limitations of Use Therapy with megestrol acetate oral suspension for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, renal disease or psychiatric diseases. Megestrol acetate oral suspension is not intended for prophylactic use to avoid weight loss.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Megestrol Acetate125MG/ML · suspension;oral | Megestrol Acetate | Rx |
| Feb 21, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jun 8, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 27, 2014 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
