New Drug Approvals

Dr. Reddy’s launches Zenatane (Isotretinoin Capsules USP) in US

April 2, 2013 4:02 am

Isotretinoin

1 APRIL, 2013

India-based Dr. Reddy’s Laboratories has announced the launch of Zenatane (Isotretinoin Capsules USP) in 20mg and 40mg strengths in the US.

The launch follows the FDA approval of the company’s ANDA for Zenatane 10mg, 20mg and 40mg.

Zenatane (Isotretinoin Capsules USP) is a generic version, therapeutically equivalent to Accutane (Isotretinoin Capsules USP).

Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne.

The company is making the product available in 10mg, 20mg, and 40mg strengths in boxes of 30 as unit dose blisters.

Isotretinoin, first marketed as Accutane byHoffmann-La Roche, is a medication used mostly for cystic acne. It is also achemotherapy treatment used in brain, pancreatic and other cancers. It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis. Its effects are systemic and nonselective. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body.

Isotretinoin’s best-known and most dangerous side effect is birth defects due to in utero exposure. This is because of the molecule’s close resemblance to retinoic acid, a natural vitamin A derivative which controls normal embryonic development. In the United States a special procedure is required to obtain the pharmaceutical (see below).

In 2009, Roche decided to pull Accutane off the US market after juries had awarded millions of dollars in damages to former Accutane users over inflammatory bowel disease claims. Among others, actor James Marshall sued Roche over Accutane-related disease that resulted in removal of his colon.

The most common brands are Roaccutane (Hoffman-La Roche, known as Accutane in the United States before July 2009), Amnesteem (Mylan), Claravis (Barr), Isotroin(Cipla) or Sotret (Ranbaxy).