LAKE FOREST, Ill., Sept. 28, 2015 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq:AKRX), a leading specialty pharmaceutical company, today announced that it has launched the recently-approved 30 mg strength of Myorisan™ (isotretinoin capsules, USP). This launch further builds the Myorisan™ product portfolio that also includes 10 mg, 20 mg and 40 mg capsules.
Akorn's Myorisan™ (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg strengths, marketed under the VersaPharm label, are indicated for the treatment of severe recalcitrant nodular acne. According to IMS Health, sales of 10 mg, 20 mg and 40 mg isotretinoin capsules were approximately $436 million for the twelve months ended July 31, 2015 while sales of the 30 mg strength were approximately $209 million over the same period.
Please refer to the approved Myorisan™ package insert for full prescribing information and dispensing instructions.
CONTRAINDICATIONS AND WARNINGS
Myorisan™ 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 Myorisan™ in any amount, even for short periods 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.
Birth defects which have been documented following Myorisan™ exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.
Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.
If pregnancy does occur during treatment of a female patient who is taking Myorisan™, Myorisan™ must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Special Prescribing Requirements
Because of Myorisan™ teratogenicity and to minimize fetal exposure, Myorisan™ is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Myorisan™ must only be prescribed by prescribers who are registered and activated with the iPLEDGE™ program. Myorisan™ must only be dispensed by a pharmacy registered and activated with iPLEDGE™, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE™ (see PRECAUTIONS).
Akorn, Inc. is a specialty pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland and Paonta Sahib, India where the Company manufactures ophthalmic, injectable and specialty sterile and non-sterile pharmaceuticals. Additional information is available on the Company's website at www.akorn.com.
Forward Looking Statements
This press release includes statements that may constitute "forward looking statements", including projections of sales and other statements regarding Akorn's launches, regulatory approvals, goals and strategy. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Factors that could cause or contribute to such differences include, but are not limited to: the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations; changes in the laws and regulations and such other risks and uncertainties outlined in Akorn's periodic public filings with the Securities and Exchange Commission and in other written or oral investor communications. Other factors besides those listed there could also adversely affect our results. Except as expressly required by law, Akorn disclaims any intent or obligation to update these forward-looking statements.
The addressable IMS market size figures presented in this press release outline the approximate aggregate size of the potential market and are not forecasts of our future sales.
Myorisan™ is a registered trademark of VersaPharm Incorporated.
iPLEDGE™ is a registered service mark of McKesson Specialty Arizona, Inc.
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