Acne drug: Zydus Lifesciences bags USFDA nod for Minocycline Hydrochloride ER tablets
The product will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, India.
Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) for Minocycline Hydrochloride Extended-Release Tablets USP, 55 mg, 65 mg, and 115 mg (USRLD: Solodyn Tablets, 55 mg, 65 mg, and 115 mg).
Minocycline Hydrochloride Extended-Release is used to treat moderate to severe acne in people 12 years and older. Minocycline belongs to a class of drugs known as tetracycline antibiotics.
The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).
Minocycline Hydrochloride Extended-Release Tablets USP, 55 mg, 65 mg, and 115 mg had annual sales of USD 0.7 mn in the United States (IQVIA MAT April 2023). The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
Medical Dialogues team had earlier reported that the company had received final approval from the USFDA to market Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% (USRLD: Epiduo Forte).
Read also: Zydus Lifesciences Topical acne treatment gel gets USFDA okay
Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.
Read also: Submit safety and efficacy data: CDSCO panel Tells Zydus on Anticancer Drug Relugolix
