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Galt Pharmaceuticals® Announces Acquisition of Cutis Health

January 22, 2017

Atlanta, GA: Galt Pharmaceuticals®, LLC announces the acquisition of Cutis Health, LLC. The transaction includes Cutis Health's prescription and non-prescription products as well as its intellectual property and registered marks. Dr. Barry Patel, President & CEO of Galt, stated, “Integrating the Cutis Health brand and generic products into the unique Galt Independent Pharmacy distribution network will create synergistic partnerships that ultimately help patients meet unmet treatment needs” As part of the deal, Galt will assume the existing Cutis Health labeler assignment and Cutis Health products currently in the distribution channels. Galt will assume the existing Cutis Health contracts, commitments and labeler assignment. Inventory currently not in distribution channels will be relabeled under Galt Pharmaceuticals® branding before distribution.

The agreement transitions an NDA (Doral®), unnamed ANDAs and a generic OTC Monograph product (lidocaine 4% cream) to Galt. “While Doral will be actively promoted by our representatives working on behalf of independent pharmacies, the generic monograph products will continue to be distributed through competitive wholesaler pricing and large purchasers” stated Galt Chairman, Dr. Wade Smith. As an example of the competitive pricing, the generic lidocaine 4% cream packaging provides twice the unit dose tubes at significantly lower pricing than existing brands.

About Galt Pharmaceuticals

Galt Pharmaceuticals® is a specialty pharmaceutical company focused on acquiring, developing and commercializing brand and generic prescription and non-prescription products through independent pharmacies Learn more at www.galtrx.com.

Important Safety Information (ISI)

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.1), Drug Interactions (7)]. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.


DORAL is contraindicated in patients with known hypersensitivity to DORAL or other benzodiazepines. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of DORAL. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Patients who develop such reactions should be treated in an emergency department and should not be rechallenged with DORAL.

DORAL is contraindicated in patients with established or suspected sleep apnea, or with pulmonary insufficiency.



CNS-Depressant Effects and Daytime Impairment: Doral can produce CNS depressant effects, including daytime impairment. Patients should be cautioned against driving and other activities requiring complete mental alertness. Alcohol generally should not be used during treatment with DORAL. Additive effects occur with concomitant use of other CNS depressants. There is an increased risk of next-day psychomotor impairment if higher than the recommended dose is taken, if co-administered with other CNS depressants, or if taken with less than a full night of sleep remaining (7-8 hours). The use of Doral and concomitant CNS depressants may require downward dose adjustment and the concomitant use of Doral with other sleep-hypnotics is not recommended.

Because DORAL can cause drowsiness and a decreased level of consciousness, patients particularly the elderly, are at higher risk of falls.

Need to Evaluate for Co-morbid Diagnoses: If insomnia worsens or fails to remit after 7 to 10 days of treatment, this might be indication of an underlying illness that should be evaluated.

Abnormal Thinking and Behavior Changes: Abnormal thinking, behavior changes, and complex behaviors such as “sleep driving” (i.e., driving while not fully awake, with amnesia for the event) and other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events. Some of these changes include decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), bizarre behavior, and depersonalization. Visual and auditory hallucinations have also been reported. Doral should be discontinued if these symptoms occur.

Worsening of Depression: Benzodiazepines may worsen depression and consequently, appropriate precautions (e.g., increased monitoring for suicidal ideation, limiting prescription size) should be considered.

Benzodiazepine Withdrawal Syndrome: A withdrawal syndrome similar to that from alcohol (e.g., convulsions, tremor, abdominal and muscle cramps, vomiting, and sweating) can occur following abrupt discontinuation of DORAL. Avoid abrupt discontinuation in at-risk patients of benzodiazepine withdrawal syndrome, particularly patients taking higher than recommended dose over an extended time, and the dose gradually tapered. Prescribers should monitor patients for tolerance, abuse, and dependence.



The most common adverse reactions (>1%) observed with DORAL were drowsiness, headache, fatigue, dizziness, dry mouth, and dyspepsia. Doral is classified as a Schedule IV controlled substance and patients treated with Doral should be monitored for tolerance, abuse, and dependence. For a full list of warnings and precautions, please refer to the full prescribing information.

Visit www.DoralRx.com for more details and full prescribing information.

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