Alembic Pharma gets six USFDA approvals for its generic formulations in Q2FY24
Source: Financial Express
According to a press statement, the Company has received six final approvals that include Chlorpromazine Hydrochloride Tablets USP, Brimonidine Tartrate Ophthalmic Solution, Guanfacine Extended-Release Tablets USP, Erythromycin Tablets USP, Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP.
Alembic Pharmaceuticals Limited on Wednesday announced that it has received US Food & Drug Administration (USFDA) approvals on six of its Abbreviated New Drug Application (ANDA) during Q2FY24.
According to a press statement, 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%, 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%/0.5%, Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg.
Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg of Upsher-Smith Laboratories, LLC., is to manage the symptoms of psychotic disorders and treatment of schizophrenia, control nausea and vomiting, relieve restlessness and apprehension before surgery, acute intermittent porphyria, adjunct in the treatment of tetanus, to control the manifestations of the manic type of manic-depressive illness and for relief of intractable hiccups.
Brimonidine Tartrate Ophthalmic Solution, 0.1% with the brand name Alphagan P Ophthalmic Solution is from the innovator AbbVie, Inc. The medication is indicated to lower elevated intraocular pressure (IOP) in patients suffering from open-angle glaucoma or ocular hypertension.
Guanfacine Extended-Release Tablets USP, 1 mg, 2 mg, 3 mg, and 4 mg by Takeda Pharmaceuticals U.S.A., Inc. and with brand name Intuniv Extended-Release Tablets is indicated for individuals suffering from Attention Deficit Hyperactivity Disorder (ADHD). The tablets can be used alone or alongside stimulant medications.
Erythromycin Tablets USP, 250 mg and 500 mg by Azurity Pharmaceuticals, Inc. for the treatment of various infections caused by certain microorganisms.
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% by AbbVie Inc. is 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 who require adjunctive or replacement therapy due to inadequately controlled IOP. The brand name for the product is Combigan Ophthalmic Solution.
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg with the brand name Librax Capsules by Bausch Health US, LLC. are indicated to control emotional and physical factors that can cause gastrointestinal disorders.
These capsules may also be used as additional treatments to help with peptic ulcers and in irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis, the company said in a statement.
