USFDA approval granted for these 5 products: Alembic

The USFDA approval for five products address a range of therapeutic needs, showcasing Alembic Pharma's commitment to developing medications for various health concerns.

The Health Master

May 9, 2024

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USFDA Drug product Approval — USFDA Approval

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Last Updated on May 17, 2024 by The Health Master

USFDA approval

Alembic Pharma, a leading Indian pharmaceutical company, has achieved a significant milestone by securing US Food and Drug Administration approval (USFDA approval) for five of its products within a short span of one month (April 1st to May 8th, 2024).

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This impressive feat strengthens their position in the US market and expands their portfolio of USFDA approved medications.

Broadening Treatment Options Across Diverse Conditions

The USFDA approval for five products address a range of therapeutic needs, showcasing Alembic Pharma‘s commitment to developing medications for various health concerns.

Here’s a closer look at each product and its potential impact:

1. Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringe (Final USFDA Approval):

This prefilled syringe containing Diazepam, a well-known medication under the brand name Valium (Hoffmann LA Roche Inc.), offers a convenient and precise way to manage anxiety disorders and provide short-term relief for anxiety symptoms.

2. Selexipag Tablets 1,000 mcg and 1,200 mcg (Tentative USFDA Approval):

This medication, with the potential brand name Uptravi (Actelion Pharmaceuticals Inc.), targets pulmonary arterial hypertension (PAH), a severe lung condition.

Selexipag helps slow disease progression and reduce hospitalization risks associated with PAH (WHO Group I).

3. Binimetinib (Tentative USFDA Approval):

In combination with encorafenib, Binimetinib, potentially marketed as Mektovi (Array Biopharm), offers a targeted therapy for patients with a specific type of aggressive skin cancer (unresesectable or metastatic melanoma) harboring a BRAF V600E or V600K mutation.

4. Tretinoin Cream USP, 0.1% (Final USFDA Approval):

A generic version of Retin-A (Bausch Health US, LLC., USA), Tretinoin Cream is a topical treatment for acne vulgaris, a common skin condition affecting millions.

5. Clindamycin Phosphate Topical Gel USP 1% (Final USFDA Approval):

Another topical medication for acne vulgaris, this generic version of Cleocin T (Clindamycin Phosphate Topical Gel) provides an alternative treatment option for patients struggling with acne.

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Building a Robust USFDA Portfolio

With these latest USFDA approvals, Alembic Pharma boasts a cumulative total of 201 ANDA (Abbreviated New Drug Application) approvals from the USFDA.

This impressive number signifies their commitment to developing high-quality generic medications that meet the stringent regulatory standards of the US market.

Alembic Pharma‘s recent USFDA approvals are a positive development for both the company and patients seeking effective and potentially more affordable treatment options.

The diversified range of approved medications addresses critical healthcare needs, solidifying Alembic Pharma’s position as a key player in the US pharmaceutical landscape.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.