1. Dabigatran Etexilate Capsules (75 and 150 mg)
From: Camber Prescription drugs
Evaluate to: Pradaxa
Camber Prescription drugs added dabigatran etexilate capsules to its new lineup of generic merchandise. As a direct thrombin inhibitor, the drug is indicated to cut back the danger of systemic embolism and strokes in grownup sufferers who’ve nonvalvular atrial fibrillation, which is an irregular coronary heart rhythm that may result in blood clots and strokes. The 75- and 150-mg capsules are available bottles containing 60 capsules. Frequent hostile occasions embody allergic reactions, gastrointestinal burning, and different abdomen space discomfort.
For Extra Data:
camberpharma.com
2. Trimethoprim Tablets USP, 100 mg
From: ANI Prescription drugs, Inc
Evaluate To: Trimethoprim Capsules
The FDA not too long ago granted tentative approval for trimethoprim tablets USP, 100 mg, following an abbreviated new drug software by ANI Prescription drugs, Inc. The brand new generic’s reference drug is trimethoprim, and it’s indicated as an antibacterial to deal with bacterial infections. Annual income for the reference drug is over $16 million, based on well being care knowledge guide IQVIA/IMS Well being.
For Extra Data:
anipharmaceuticals.com
3. Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL
From: Alembic Prescription drugs Restricted
Evaluate To: Toradol Injection, 15 and 30 mg/mL, and 60 mg/2 mL
The FDA granted approval to Alembic Pharmaceutical Restricted’s abbreviated new drug software for Ketorolac tromethamine injection USP, at 15 and 30 mg/mL and 60 mg/2 mL dosage strengths, which are available single-dose vials. The reference drug is Roche Palo Alto LLC’s Toradol injection in the identical dosage strengths. Alembic’s second injectable product approval from the corporate’s basic sterile facility is indicated for adults to handle reasonably extreme acute ache for five days or fewer. The Ketorolac tromethamine injection has an estimated US market dimension of $59 million, based on well being care knowledge guide IQVIA.
For Extra Data:
alembicusa.com
4. Lidocaine and Prilocaine Cream, 2.5%/2.5%
From: Alembic Prescription drugs Inc
Evaluate To: Emla Cream
Alembic Prescription drugs, Inc’s Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5-gm tubes can be found and transport. It’s indicated to be used as a topical anesthetic to be used on regular intact pores and skin or genital mucous membranes for minor surgical procedure and as a pretreatment for infiltration anesthetic. Frequent hostile occasions embody alterations in temperature sensation, edema, itching, paleness, rash, and redness. A thick layer of cream must be used and lined with dressing for intact pores and skin and used an hour earlier than a process if used on genital mucous membranes for minor surgical procedure.
For Extra Data:
alembicusa.com
