Generic Product News for January 2023

Pharmacy TimesJanuary 2023
Volume 89
Issue 1

Products include drugs for patients with stroke, bacterial infections, and acute pain.

1. Dabigatran Etexilate Capsules (75 and 150 mg)

From: Camber Pharmaceuticals

Compare to: Pradaxa

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

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2. Trimethoprim Tablets USP, 100 mg

From: ANI Pharmaceuticals, Inc

Compare To: Trimethoprim Capsules

The FDA recently granted tentative approval for trimethoprim tablets USP, 100 mg, following an abbreviated new drug application by ANI Pharmaceuticals, Inc. The new generic’s reference drug is trimethoprim, and it is indicated as an antibacterial to treat bacterial infections. Annual revenue for the reference drug is over $16 million, according to health care data consultant IQVIA/IMS Health.

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

From: Alembic Pharmaceuticals Limited

Compare To: Toradol Injection, 15 and 30 mg/mL, and 60 mg/2 mL

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

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

From: Alembic Pharmaceuticals Inc

Compare To: Emla Cream

Alembic Pharmaceuticals, Inc’s Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5-gm tubes are available and shipping. 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 alterations in temperature sensation, edema, itching, paleness, rash, and redness. A thick layer of cream should be used and covered with dressing for intact skin and used an hour before a procedure if used on genital mucous membranes for minor surgery.

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