Alembic Pharma Secures Six FDA Approvals

India Pharma Outlook Team | Wednesday, 04 October 2023

 India Pharma Outlook Team

Alembic Pharmaceuticals Limited stated that six of its abbreviated new drug applications (ANDA) were approved by the US Food and Drug Administration (US FDA) during Q2FY24. The company has received six final approvals that include Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, Brimonidine Tartrate Ophthalmic Solution, 0.1 per cent, Guanfacine Extended-Release Tablets USP, 1 mg, 2 mg, 3 mg, and 4 mg, Erythromycin Tablets USP, 250 mg and 500 mg,

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2 per cent /0.5 per cent, Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg, as per ETHealthWorld. Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg are manufactured by Upsher-Smith Laboratories, LLC, and are used to treat schizophrenia, control nausea and vomiting, relieve anxiety and restlessness before surgery, treat acute intermittent porphyria, treat tetanus, manage the symptoms of manic-depressive illness, and treat intractable hiccups.

The pioneer AbbVie, Inc. manufactures Brimonidine Tartrate Ophthalmic Solution 0.1 percent, under the trade name Alphagan P Ophthalmic Solution. The drug is intended to decrease open-angle glaucoma or ocular hypertension patients' increased intraocular pressure (IOP). ADHD sufferers should use Guanfacine Extended-Release Tablets USP, 1 mg, 2 mg, 3 mg, and 4 mg, manufactured by Takeda Pharmaceuticals US, Inc. and sold under the trade name Intuniv Extended-Release Tablets. The pills may be used either on their own or with other stimulant drugs

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