Generic Oracea one step closer, Lupin gets Tentative FDA Approval

Written by David Pascoe on August 1, 2013 in in the news, Oracea (40mg doxycycline) with 0 Comments

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News today that Lupin has been granted tentative approval by the FDA to product a generic version of Oracea.

We learn in 2010 that Lupin had filed an abbreviated new drug application to make generic Oracea.

Lupin Pharmaceuticals, based in Mumbai India, is a company specialising in the production of generic medicines.

It has been a slow process, but those who want to include Oracea in their treatment regime, but cannot afford the expensive prescriptions will be glad to hear Generic Oracea is coming c

Lupin gets Tentative FDA Approval for Generic Oracea Capsules

Mumbai, Baltimore, July 31, 2013:

Pharma Major Lupin Limited announced today that its U.S. subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for its Armodafinil Tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths as well as another tentative approval for its Doxycycline Capsules, 40 mg (30 mg Immediate-release and 10 mg Delayed-release) from the United States Food and Drugs Administration (FDA).

Lupin’s Doxycycline Capsules is the AB-rated generic equivalent of Galderma Laboratories Oracea Capsules, 40 mg. Doxycycline Capsule is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

Oracea Capsules had annual U.S sales of approximately $319 mn for the twelve months ending March, 2013