Drug-maker Glenmark Pharmaceuticals’ Apremilast Tablets, 10 mg, 20 mg and 30 mg, a generic version of Amgen’s Otezla Tablets, 10 mg, 20 mg and 30 mg, has received final approval from the United States Food and Drug Administration (U.S. FDA).

Otezla Tablets brand and therapeutic equivalents achieved annual sales of around $3.7 billion, Glenmark said citing IQVIA sales data for the 12-month period ending August 2023.

A phosphodiesterase 4 (PDE4) inhibitor, Apremilast is indicated for treating psoriatic arthritis plaque psoriasis and Behcet disease associated with oral ulcers.

Glenmark said its portfolio consists of 188 products authorised for distribution in the U.S. market while 50 abbreviated new drug applications (ANDAs) are pending approval with the U.S. FDA. It also continued to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Pristine Delhi:

Glenmark Prescription drugs is recalling 1,200 bottles of a generic drug, old to regard hypertension, within the American marketplace because of a producing factor, consistent with the United States Meals and Drug Management (USFDA). 

The Pristine Jersey-based arm of the drug company is recalling 1,200 bottles of Trandolapril and Verapamil Hydrochloride extended-release pills, as consistent with the fresh Enforcement File of the United States condition regulator.

The affected quantity has been manufactured on the Goa plant of the Mumbai-based drug company and after provided to Glenmark Prescription drugs Inc, USA, the USFDA stated.

The company is recalling the affected bottles because of it being “Subpotent”, it famous.

Glenmark Prescription drugs Inc initiated the national (US) Magnificence III recall on August 14 this day, it added.

As consistent with the USFDA, a Magnificence III recall is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”. 

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