Healthcare Industry News:  tetracycline 

Biopharmaceuticals Generics FDA

 News Release - May 12, 2006

Barr Receives Approval for Isotretinoin Capsules USP, 30 mg

Represents Fourth Strength in Company's Claravis(TM) Product Line

WOODCLIFF LAKE, N.J., May 12 (HSMN NewsFeed) -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today announced that its subsidiary, Barr Laboratories, Inc., received approval from the U.S. Food & Drug Administration (FDA) for its application to manufacture and market Isotretinoin Capsules USP, 30 mg. The Company will launch the product immediately under the tradename Claravis(TM). The Company will now market the full line of Isotretinoin product strengths, including Claravis 10 mg, 20 mg, 30 mg and 40 mg capsules.

Claravis Capsules, 30 mg will compete with Ranbaxy's Sotret® (Isotretinoin) Capsules USP, 30 mg that had total annual sales of approximately $15 million for the most recent twelve months ending March 2006, based on IMS data.

The Reference Listed Drug at the FDA is Roche's Accutane® product, though Roche does not market a 30 mg strength. Ranbaxy filed a Suitability Petition with the FDA seeking permission to file an Abbreviated New Drug Application (ANDA) for a change from the listed drug, Accutane, in dosage strength of 30 mg. Upon receiving approval for their Suitability Petition, Ranbaxy filed an ANDA for Isotretinoin Capsules USP, 30 mg in September 2002. Ranbaxy received FDA approval for its ANDA in June 2003 and currently markets the product under the tradename Sotret. Barr filed a Supplemental Abbreviated New Drug Application (sANDA) for the 30 mg strength of Isotretinoin Capsules USP with the FDA in June 2004 seeking approval to manufacture market this additional strength. Today's approval continues to demonstrate Barr's ability to successfully develop complex generic products.

Claravis is indicated for the treatment of severe recalcitrant nodular acne. Because of the significant adverse effects associated with its use, Claravis should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, for female patients of childbearing potential, Claravis is indicated only for those females who are not pregnant and will not become pregnant.


Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for a short period of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Because of this toxicity, isotretinoin can only be marketed under a special restricted distribution program. This program is called iPLEDGE(TM). Under this program, prescribers must be registered and activated with the iPLEDGE program and can prescribe isotretinoin only to registered patients who meet all the requirements of iPLEDGE. Isotretinoin can be dispensed only by a pharmacy registered and activated with iPLEDGE. Registered and activated pharmacies can only receive isotretinoin from wholesalers registered with iPLEDGE.

Patients on isotretinoin have been known to become depressed or to develop other serious mental health problems. Some people have had thoughts of hurting themselves or putting an end to their own lives. Some people tried to end their own lives and some have ended their own lives. There have been reports that people on isotretinoin were aggressive or violent. No one knows if isotretinoin caused these problems or behaviors or if they would have happened even if the person did not take isotretinoin. Isotretinoin use has been associated with a condition caused by increased pressure on the brain. This condition may occur more often in patients also taking tetracycline. Patients should be aware of other serious side effects, including problems with the pancreas, liver, stomach, bones, muscles, hearing, vision, lipids, allergic reactions, blood sugar, or red and white blood cells. The most common, less serious adverse events include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Patients should be advised about these adverse events and routinely monitored by a doctor during treatment with isotretinoin.

Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2005.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.

Source: Barr Pharmaceuticals

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