Press Release USFDA Products Approval dated 9th May, 2024
2024-05-01 · Alembic Pharmaceuticals Ltd. · original alembicpharmaceuticals.com ↗
ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123 Date: 9th May, 2024 To, The Manager, Department of Corporate Services, BSE Limited P. J. Towers, Dalal Street, Fort, Mumbai – 400 001 BSE Scrip Code: 533573 To, The Manager, Listing Department, National Stock Exchange of India Ltd. ‘Exchange Plaza’, Bandra Kurla Complex, Bandra (E), Mumbai – 400 051 NSE Symbol: APLLTD Dear Sir/Madam, Sub: Alembic Pharmaceuticals Limited receives various US Food & Drug Administration (USFDA) (Tentative or Final) product approvals. This is to inform the exchanges that the Company has received various US Food & Drug Administration (USFDA) (Tentative or Final) Product Approvals. The summary statement giving brief of all product approvals receiv ed from 1st April, 2024 till 8th May, 2024 is enclosed for your information and records. Alembic has a cumulative total of 201 ANDA approvals (17 3 final approvals and 2 8 tentative approvals) from USFDA. We request you to kindly take the same on record. Thanking you, Yours faithfully, For Alembic Pharmaceuticals Limited Manisha Saraf Company Secretary Encl.: A/a. ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123 Annexure Summarized Product Approval received 1st April, 2024 till 8th May, 2024. Product Name Approval Final/ Tentative Innovator Name Brand name Indication* Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single - Dose Prefilled Syringe Final Hoffmann LA Roche Inc Valium® (Diazepa m) Injection Diazepam Injection USP Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Selexipag Tablets 1,000 mcg and 1,200 mcg. Tentative Actelion Pharmaceut icals Inc. Uptravi Selexipag tablets are indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. Binimetinib Tentative Array Biopharm Mektovi Binimetinib tablet is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Tretinoin Cream USP, 0.1%, Final Bausch Health US, LLC., USA Retin-A Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris. Clindamycin Phosphate Topical Gel USP 1% Final Pharmacia & Upjohn Cleocin T Clindamycin phosphate gel is indicated in the treatment of acne vulgaris *Refer label for full indication
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