Alembic Pharmaceuticals Secures USFDA Approvals for Six Medications in Q2FY24

2 Jan 2024 , 11:22 AM

Alembic Pharmaceuticals Limited has successfully obtained approvals from the US Food & Drug Administration (USFDA) for six Abbreviated New Drug Applications (ANDA) during the second quarter of the fiscal year 2024.

Approved Medications: 

Chlorpromazine Hydrochloride Tablets USP:

• Various strengths: 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.
• Manufactured by Upsher-Smith Laboratories, LLC.
• Indicated for managing symptoms of psychotic disorders and schizophrenia, controlling nausea and vomiting, relieving restlessness and apprehension before surgery, acute intermittent porphyria, adjunct in the treatment of tetanus, and more.

Brimonidine Tartrate Ophthalmic Solution:

• Strength: 0.1%.
• Branded as Alphagan P Ophthalmic Solution (AbbVie, Inc.).
• Indicated to lower elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Guanfacine Extended-Release Tablets USP:

• Strengths: 1 mg, 2 mg, 3 mg, and 4 mg.
• Marketed as Intuniv Extended-Release Tablets by Takeda Pharmaceuticals U.S.A., Inc.
• Indicated for individuals suffering from Attention Deficit Hyperactivity Disorder (ADHD), either as monotherapy or in combination with stimulant medications.

Erythromycin Tablets USP:

• Strengths: 250 mg and 500 mg.
• Provided by Azurity Pharmaceuticals, Inc.
• Used for treating various infections caused by specific microorganisms.

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution:

• Strength: 0.2%/0.5%.
• Branded as Combigan Ophthalmic Solution by AbbVie Inc.
• An alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor, indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP:

• Strength: 5 mg/2.5 mg.
• Branded as Librax Capsules by Bausch Health US, LLC.
• Indicated for controlling emotional and physical factors causing gastrointestinal disorders, peptic ulcers, irritable bowel syndrome, and acute enterocolitis.

About Alembic Pharmaceuticals Ltd: Alembic Pharmaceuticals Ltd., based in Vadodara, India, is a multinational pharmaceutical company engaged in the manufacturing of pharmaceutical products, pharmaceutical substances, and intermediates.
 

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