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Alembic Pharmaceuticals has received various US Food &
Drug Administration (USFDA) (Tentative or Final) product approvals during the period 01 April 2024 to 08 May 2024. These include:
- Final approval for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), SingleDose Prefilled Syringe
Diazepam Injection USP Diazepam is indicated for the management of
anxiety disorders or for the short-term relief of the symptoms of
anxiety.
- Tentative approval for Selexipag Tablets 1,000 mcg and 1,200 mcg.
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.
- Tentative approval for Binimetinib
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.
- Final approval for Tretinoin Cream USP, 0.1%
Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris.
- Final approval for Clindamycin Phosphate Topical Gel USP 1%
Clindamycin phosphate gel is indicated in the treatment of acne vulgaris.
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