New Generic Launches


New launches this week include: new strength of Alimta, a generic of Esbriet, a generic of Toradol, and a generic of Florinef.

Fresenius Kabi Introduces New Strength of Generic of Anticancer Alimta

Fresenius Kabi of PEMEtrexed, a generic equivalent to Lilly’s Alimta, which is used to treat non-squamous non-small cell lung cancer, is now available in an additional strength for intravenous use. It is available as:

  • PEMEtrexed for Injection, USP 100 mg per single-dose vial
  • PEMEtrexed for Injection, USP 500 mg per single-dose vial
  • New strength: PEMEtrexed for Injection, USP 750 mg per single-dose vial
  • New strength: PEMEtrexed for Injection, USP 1 gram per single-dose vial

PEMEtrexed, along with other oncology medicines, is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program that offers copay assistance to eligible U.S. patients. The program can lower out-of-pocket costs to as little as $0 per month for eligible patients.

Accord Healthcare Launches Generic of Esbriet

Accord Healthcare added pirfenidone to its oral solid products portfolio. The new drug is therapeutically equivalent to Genentech’s Esbriet and approved to treat idiopathic pulmonary fibrosis (IPF), a lung disease that involves scarring of the lungs.

The new product, offered in 267 mg and 801 mg tablets, is currently available.

Dr. Reddy’s Makes Generic Toradol Available

Dr. Reddy’s and Senores Pharmaceuticals have launched ketorolac tromethamine tablets, a generic of Toradol, a brand that is no longer on the market. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the short-term management of moderately severe acute pain. It is used for pain too severe for nonprescription NSAIDS, and is considered to be a short-term (no more than five days) substitute for opioids.

The generic is available in10 mg tablets in bottle count sizes of 100.

ANI Announces FDA Approval and Launch of Fludrocortisone

ANI Pharmaceuticals has announced that FDA has approved its abbreviated new drug application (ANDA) for fludrocortisone acetate tablets, the generic equivalent of Florinef, which is used as a partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease. In patients with Addison’s, the adrenal glands produce too little cortisol and aldosterone.

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