Stream of new generic products hits the market.
NEW YORK -- New generic drugs are arriving on the market by way of Abbreviated New Drug Application (ANDA) approvals, authorized generics and supply agreements.
Recently, ANI Pharmaceuticals Inc. entered into a supply and distribution agreement with Aspen Global Inc. for hydroxyprogsterone caproate injection USP. ANI also recently launched an authorized generic of Rowasa, indicated for the treatment of mild to moderate ulcerative colitis.
Aurolife Pharma LLC, a division of Aurobindo Pharma USA, received ANDA approval for oxymorphone hydrochloride tablets, 5 mg and 10 mg. The product is bioequivalent and therapeutically equivalent to Opana tablets (Endo Pharmaceuticals Inc.).
Aurobindo received final ANDA approval for fenofibrate tablets, 48 mg and 145 mg. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Tricor (Abbvie Inc.).
Camber Pharmaceuticals launched methylphenidate tablets, (5, 10 and 20 mg tablets) a generic version of Ritalin. The drug is used to treat attention deficit hyperactivity disorder and narcolepsy.
Mylan N.V. announced the U.S. launch of hydralazine hydrochloride injection USP, 20 mg/mL, which is a generic version of Novartis AG's Apresoline Injection, 20 mg/mL. Mylan received final approval from the FDA for its ANDA for this product, which is used for the treatment of severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
Hydralazine hydrochloride Injection USP, 20 mg/mL, had U.S. sales of approximately $63.4 million for the 12 months ended March 31, 2016, according to IMS Health. Mylan's launch of this product adds to the company's growing portfolio of more than 150 injectable products available to patients in the U.S. across a broad array of therapeutic categories including oncology, anti-infectives, anesthesia/ pain management and cardiovascular.
Teligent Inc., a New Jersey-based specialty generic pharmaceutical company, has received approval of its ANDA for triamcinolone acetonide ointment USP, 0.1%, the fifth approval from its internally developed pipeline of topical generic pharmaceutical products.
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|Title Annotation:||RX: RETAIL PHARMACY: Generic Drugs|
|Publication:||Chain Drug Review|
|Date:||Jun 6, 2016|
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