Generics News for January 2023

1. Dabigatran Etexilate Capsules (75 and 150 mg)

From: Camber Pharmaceuticals

Compared topradaxa

Camber Pharmaceuticals has added dabigatran etexilate capsules to its new generic product line. As a direct thrombin inhibitor, the drug is indicated to reduce the risk of systemic embolism and stroke in adult patients with non-valvular atrial fibrillation, which is an irregular heart rhythm that can lead to blood clots and stroke. The 75 and 150 mg capsules come in bottles containing 60 capsules. Common adverse events include allergic reactions, gastrointestinal burning and other discomforts in the stomach area.

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2. Trimethoprim USP Tablets, 100 mg

From: ANI Pharmaceuticals, Inc

Compared to: Trimethoprim capsules

The FDA recently granted provisional approval for Trimethoprim Tablets USP, 100 mg, following an abbreviated new drug application by ANI Pharmaceuticals, Inc. The new generic reference medicine is trimethoprim, indicated as an antibacterial to treat bacterial infections. Annual prescription for the branded drug is more than $16 million, according to health data consultant IQVIA/IMS Health.

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3. Injection of Ketorolac Tromethamine USP, 15 mg/mL, 30 mg/mL and 60 mg/2 mL

From: Alembic Pharmaceuticals Limited

Compared to: Toradol injection, 15 and 30 mg/mL and 60 mg/2 mL

The FDA has granted approval for Alembic Pharmaceutical Limited’s abbreviated new drug application for Ketorolac Tromethamine Injection USP, in strengths of 15 and 30 mg/mL and 60 mg/2 mL, which come in single-dose vials. The reference drug is Roche Palo Alto LLC’s Toradol injection at the same dosages. The approval of Alembic’s second injectable product from the company’s general sterile facility is indicated for adults in the treatment of moderately severe acute pain for 5 days or less. Ketorolac tromethamine injection has an estimated US market size of $59 million, according to health data consultant IQVIA.

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4. Lidocaine and Prilocaine Cream, 2.5%/2.5%

From: Alembic Pharmaceuticals Inc

Compared to: Cream Emla

Alembic Pharmaceuticals, Inc’s Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 g tubes are available and shipped. It is indicated for use as a topical anesthetic for use on normal intact skin or genital mucous membranes for minor surgery and as a pretreatment for infiltration anesthetic. Common adverse events include changes in temperature sensation, swelling, itching, pallor, rash, and redness. A thick layer of cream should be used and covered with dressing for intact skin and used one hour before a procedure if used on genital mucous membranes for minor surgery.

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Generics News for January 2023

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