FDA WARNING_LETTER - Glenmark Pharmaceuticals Inc.

On March 16, 2010, the FDA issued a Warning Letter to Glenmark Generics Inc. regarding their marketing of unapproved new drugs: Nitroglycerin Tablets, 0.3 mg, 0.4 mg, and 0.6 mg.

The FDA determined these products are "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their labeled uses. Consequently, their introduction into interstate commerce without an FDA-approved application (violating sections 301(d) and 505(a) of the Act) makes them unapproved new drugs.

Additionally, the products are misbranded under section 502(f)(1) of the Act because they are intended for conditions not amenable to self-diagnosis, and their labeling lacks adequate directions for lay use. This also violates sections 301(a) and (d) of the Act.

The FDA stated it would exercise enforcement discretion, not initiating action for manufacturing continuing within 90 days of the letter, or for shipments continuing within 180 days. This discretion would not apply if other violations occur, distribution volume increases, or new serious health risks emerge.

Glenmark Generics Inc. was required to respond within fifteen working days, stating their plan to cease violative activities, including reasons and dates if production ceased, and identifying any other manufacturers or suppliers