| Company |
Trade Name |
Generic Name |
Action |
|
Amneal Pharmaceuticals Co. GmbH, Alvogen Pine Brook LLC, Natco Pharma Ltd., Par Pharmaceutical Inc., Sun Pharmaceutical Industries Ltd., Watson Laboratories Inc., West-Ward Pharmaceuticals International Ltd., Zydus Pharmaceuticals (USA) Inc.
|
|
bosentan tablets |
FDA approved generic version of Tracleer by Actelion Pharmaceuticals US Inc. for the treatment for pulmonary arterial hypertension.
|
| Aurobindo Pharma Ltd. |
|
amoxicillin and clavulanate potassium for oral suspension USP
|
FDA approved generic version of Augmentin by GlaxoSmithKline for treatment of lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections, and urinary tract infections.
|
|
Ayala Pharmaceuticals
|
AL101
|
|
FDA granted orphan drug designation for the treatment of adenoid cystic carcinoma.
|
|
Bionpharma Inc., Hikma Pharmaceuticals International Ltd.
|
|
rufinamide oral suspension |
FDA approved generic version of Banzel by Eisai Inc. for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.
|
|
Custopharm, Inc.
|
|
valrubicin intravesical solution |
FDA approved generic version of Valstar by Endo Pharmaceuticals Inc. for the intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
|
|
Eli Lilly and Co.
|
Cyramza
|
|
FDA approved Cyramza for the treatment of patients with hepatocellular carcinoma who have an alpha-fetoprotein of ≥400 ng/mL and have been treated with sorafenib.
|
|
FoldRx
|
Vyndaqel and Vyndamax
|
tafamidis meglumine and tafamidis
|
FDA approved the product for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis in adults.
|
|
Genentech
|
Venclexta in combination with Gazyva
|
venetoclax in combination with obinutuzumab |
FDA approved the product for the treatment of people with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
|
|
Hi-tech Pharmacal Co. Inc.
|
|
loteprednol etabonate ophthalmic suspension, 0.5%
|
FDA approved generic version of Lotemax by Bausch & Lomb Inc. for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis.
|
|
Jacobus Pharmaceutical Co.
|
Ruzurgi |
amifampridine
|
FDA approved the product for the treatment of Lambert-Eaton myasthenic syndrome in patients 6 to less than 17 years of age.
|
|
Mylan Pharmaceuticals, Inc.
|
|
everolimus tablets for oral suspension
|
FDA approved generic version of Afinitor Disperz by Novartis for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.
|
|
Pfizer
|
Fragmin |
dalteparin sodium injection
|
FDA approved Fragmin to reduce the recurrence of symptomatic venous thromboembolism in pediatric patients one month of age and older.
|
|
Seton Pharmaceuticals LLC
|
|
pentamidine isethionate for inhalation solution
|
FDA approved generic version of NebuPent by APP Pharmaceuticals Inc. for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high risk, HIV-infected patients defined by one or both of the following crtieria: (i) a history of one or more episodes of PJP; (ii) a peripheral CD4+ lymphocyte count less than 200/mm.
|
|
Sunovion and PsychoGenics
|
SEP-363856
|
|
FDA granted breakthrough therapy designation for treating people with schizophrenia.
|
|
Taro Pharmaceuticals USA Inc.
|
|
naftifine hydrochloride gel USP 2%
|
FDA approved generic version of Naftin by Sebela Pharmaceuticals Inc. for the treatment of interdigital tinea pedis.
|