Julianne Stein is managing editor for Drug Topics magazine.

Julianne Stein, Content Channel Manager

’ legal compliance columnist, has joined the Business Services Practice Group of the law firm of Roetzel & Andress as partner in its Chicago office and head of the firm’s Drug and Pharmacy practice.

	“We welcome Ned to our firm and are thrilled to add his knowledge and experience in medical device, drug and pharmacy law to our practice at Roetzel,” said Chicago Partner-in-Charge Mark D. Belongiain a prepared statement. “Ned’s background as both an attorney and as a Doctor of Pharmacy will be a tremendous asset in representing and counseling our clients in a very dynamic sector of the law and of the U.S. economy. 

	Milenkovich’s legal practice focuses on medical device, drug, and pharmacy law, and encompasses federal and state regulatory compliance, licensing, transactions, and dispute resolution. His clients represent all segments of the drug supply chain, among them manufacturers, wholesale distributors, third-party logistics providers, and pharmacy retailers (including brick-and-mortar retail, long-term care, mail-order, and specialty pharmacies), as well as pharmacy technology companies, prescription management companies, and physician practices. 

	His broad base of experience also includes representation of Medicare Part D matters, 340B issues, HIPAA compliance, prescription drug monitoring programs, drug diversion issues, drug pedigree and compounding issues.

	Asked to name the foremost concerns challenging the industry today, Milenkovich told 

, "In my opinion, there are several present and forthcoming issues that pharmacy industry stakeholders will continue to face: controlled substance diversion issues, sterile compounding issues (particularly in the wake of the NECC tragedy), technology and the delivery of patient care through automated dispensing units, drug pedigree issues, and 340B issues."

	He added, "Some of these issues, such as compounding and drug pedigree, may be federalized eventually, but in any event we can see them plaguing pharmacies every day. There are, of course, an endless number of other issues that remain challenges to the industry, such as fraud and abuse allegations, and reimbursement challenges (including payor audits and clawbacks), to name a few. Finally, notwithstanding the political jousting taking place in our nation's capitol over the Affordable Care Act, new opportunities for pharmacist involvement will continue to unfold in this arena as well."

	Most recently Milenkovich was chair of the Drug and Pharmacy Practice at McDonald Hopkins, LLC. He is vice chairman of the Illinois State Board of Pharmacy and a frequent lecturer at legal and pharmaceutical industry events. He earned his JD 

 from The John Marshall Law School, his PharmD with honors from the University of Illinois, and his BS in Pharmacy from The Ohio State University.

Articles

Drug Topics’ legal compliance columnist named partner in Roetzel's Chicago office and head of the firm’s Drug and Pharmacy practice.

Milenkovich joins Roetzel & Andress

	Antares Pharma has announced FDA approval of Otrexup, a drug/device version of methotrexate that delivers 0.4 mL of drug by disposable, single-dose, subcutaneous auto-injector in 10-mg, 15-mg, 20-mg, and 25-mg dosage strengths, for treatment of rheumatoid arthritis (RA) and psoriasis. Injected by the patient underneath the skin once a week, the product is intended for adults with severe RA who have shown inadequate response to full-dose nonsteroidal anti-inflammatory drugs, children with polyarticular juvenile idiopathic arthritis, and adults with severe, resistant, disabling psoriasis when other types of treatment have been used and did not work well. Otrexup should not be used for the treatment of children with psoriasis. Common side effects of Otrexup include nausea, stomach pain, indigestion (dyspepsia), mouth sores, and rash. Other side effects include fertility problems, certain cancers, and tissue and bone problems. The product carries a boxed warning about severe reactions, including embryofetal toxicity and organ toxicity that may affect the gastrointestinal system, bone marrow, liver, immune system, nervous system, lungs, kidneys, and skin, and increase the risk of death. Contraindications include pregnancy, nursing mothers, alcoholism or liver disease, immunodeficiency syndromes, preexisting blood dyscrasias, and hypersensitivity to methotrexate. This product can interact with aspirin, NSAIDs, and steroids, and proton pump inhibitors. (

Last month, FDA approved vortioxetine (Brintellix, Takeda/Lundbeck) tablets in 5-mg, 10-mg, and 20-mg strengths to treat adults with major depressive disorder (MDD). Symptoms of MDD include mood changes and disrupted work, sleep, study, meals, and pastimes previously found pleasurable. Vortioxetine was found an effective treatment for depression in six clinical studies. Another study showed that it decreased the likelihood that depression would recur. The most common side effects included nausea, constipation, and vomiting. The product carries a boxed warning and a medication guide alerting patients and healthcare professionals to increased risk of suicidal thoughts and behavior in children, adolescents, and young adults 18 to 24 years of age. Patients beginning antidepressant therapy should be closely monitored for worsening of their depression and the emergence of suicidal thoughts and behavior. 

	FDA has approved Bayer's riociguat (Adempas) tablets, a new class of drug (sGC, a stimulator of soluable guanylate cyclase), formulated to treat adults with either (i) persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class; or (ii) pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class, and delay clinical worsening. It is the first and only drug approved by FDA for treatment of two forms of pulmonary hypertension. It is also the only approved oral therapy in PAH with efficacy shown in monotherapy or in combination with ERAs or prostanoids. It is available to all female patients only through a REMS program and carries a boxed warning of embryofetal toxicity. Most commonly reported adverse reactions include headache, dyspepsia/gastritis, dizziness, nausea, diarrhea, hypotension, vomiting, anemia, gastroesophageal reflux disease, and constipation. Contraindications include pregnancy, co-administration with nitrates or nitric oxide donors, and concomitant administration with phosphodiesterase (PDE) inhibitors. 

	Pfizer announced in October that FDA had approved its formulation of conjugated estrogens â¨0.45 mg/bazedoxifene 20 mg (Duavee), which it is developing with Ligand Pharmaceuticals, to treat women with moderate to severe menopause symptoms and to prevent postmenopausal osteoporosis, which would reduce the risk of fractures. Duavee is the first and only therapy to pair conjugated estrogens with an estrogen agonist/antagonist, also known as a selective estrogen receptor modulator. The company expects this product to reduce hot flashes with fewer side effects than are produced by older hormone-replacement therapies. The product carries a boxed warning for increased risk of endometrial cancer, cardiovascular disorders, and probable dementia. Common adverse reactions in clinical tests included muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain. Contraindications include undiagnosed abnormal uterine bleeding; history of breast cancer; estrogen-dependent neoplasia; history of venous or arterial thromboembolism; hypersensitivity (angioedema,anaphylaxis) to estrogens, bazedoxifene, or other ingredients;  hepatic impairment or disease; protein C, protein S, or antithrombin deficiency or other known â¨thrombophilic disorders; and potential pregnancy, pregnancy, or breast-feeding. Patients taking Duavee should add supplemental calcium and/or vitamin D to their diets if their daily intake is inadequate. The product is packaged in two blisters of 15 tablets each. The company expects to start shipping the product by February 3, 2014.

Last month Teva announced the U.S. launch of its paricalcitol tablets, the generic equivalent to AbbVie’s Zemplar, in 1-mcg, 2-mcg, and 4-mcg strengths. Because Teva was first to file, the product will have 180 days of marketing exclusivity. Paricalcitol is an active form of vitamin D used to prevent and treat secondary hyperparathyroidism (increased parathyroid hormone levels) in patients with Stage 3 or 4 chronic kidney disease and in Stage 5 patients on dialysis. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting parathyroid hormone synthesis and secretion. 

so in October, FDA approved Teva's tobramycin inhalation solution, a generic version of Novartis’ Tobi, an inhaled antibiotic for treating lung infections in patients with cystic fibrosis. Teva expects to launch its generic product by the end of this month. 

	Mylan has launched its voriconazole for oral suspension in the 40-mg/mL strength, the first generic version of Pfizer’s Vfend for treatment of invasive fungal infections. As the first company to receive approval for a generic version, Mylan has 180 days in which to compete exclusively against Pfizer's product. 

	Also recently approved is Sun Pharmaceutical’s lansoprazole in delayed-release capsules (15 mg and 30 mg), a generic version of Takeda's Prevacid, for treatment of active duodenal ulcers. 

The Klean Athlete nutritional supplement line from Douglas Laboratories has launched KLEAN-D, a vitamin D supplement designed to aid in muscle recovery and help support immunity and musculoskeletal strength in athletes. The product is NSF-Certified for Sport, meaning that it has been tested and found to be free of banned substances. It is estimated that 1 billion people are deficient in vitamin D. (These statements have not been evaluated by FDA. These products are not intended to diagnose, treat, cure or prevent any disease.) Other items in this product line include Klean Multivitamin, Klean Antioxidants, Klean Cognitive, Klean Probiotic, Klean Isolate, Klean Electrolytes, and Klean Endurance. 

	In October, the HealFast Skincare line from Fortitude Health LLC announced the release of Scarblock cream, specifically formulated to prevent scarring after plastic surgery or injuries. It can be applied soon after surgery, while stitches are still in place. The product contains vitamins, minerals, and proteins, including 

 (Everlasting) flower oil, said to help fade scars, heal stretch marks, and reduce the appearance of surgical scars and skin blemishes. According to the manufacturer, the diketones in this essential oil help reduce scar tissue and stimulate the growth of new skin tissue. The product is also intended to soothe, nourish, and hydrate the skin, and promote collagen production. It may diminish the appearance of older scars. It contains no paraben, synthetic fragrances, or artificial colors, and no animal testing was involved in its development. A .5-oz six-week supply retails for $50. 

An OTC product appropriate to the season is TheraNeem Naturals’ Soothing Therape Chest Rub from Organix-South. This bronchial support cream is formulated with botanically derived adapatogens, antioxidants, and essential oils to soothe discomfort from minor bronchial irritations during the cold-and-flu months. According to the manufacturer, menthol and eucalyptus vapors help to open airways and promote relaxation, while extracts of holy basil, ashwagandha, neem, and tea tree oil protect and warm the skin. The product can be applied to the chest, throat, nose and back. The cruelty-free logo appears on the package.

		Also suitable for the time of year is Thumbs Up from Amazing Grace Super Naturals, a spray formulated for use on the painful skin splits and cuts that start to appear in winter on the corners of thumbs and fingers. The product’s blend of healing ingredients is derived from nature and includes honey, apple cider vinegar, rosemary essential oil, lemon, and aloe vera. Enough spray should be applied to soak the split skin. According to the manufacturer, there may be a slight stinging sensation; pain relief should follow. Application can be repeated until healing is complete. This product is available at grocery and drug retailers, organic and natural retailers, and outdoor and sporting goods retailers. It also can be ordered from the product website.

Product updates for pharmacists: New Rx, generic, and OTC

New Products

	Late-stage middle-agers can hearken back to a time when the only lip-care options around were ChapStick (cherry-flavored or original) and petroleum jelly. Folks weren’t thinking about other alternatives, because they hadn’t been invented yet. No one felt deprived.

	Flash forward to 2013 and prepare to explore the brave new world of lip products, courtesy of your favorite search engine and the internet.

	You will quickly learn that its public takes lip balm 

 seriously, as evidenced by the cascade of opinions, interest groups, and dedicated blogs that pours forth from your screen. And that’s not counting the manufacturers’ product sites.

	What is everyone getting so excited about? For starters, there are liquid lip balms, solid lip balms, roll-on lip balms, and stick lip balms. If you look, you’ll find a Cheetos-flavored lip balm, vegan lip balm, diet lip balm, and lip balms pegged to every imaginable color, flavor, fruit, flower, season, weather event, emotional state, and flirtation behavior. (Lip balm is writ in a poetic language all its own. Examples below.)

	There are lip treatments, lip therapies, lip soothers, lip moisturizers, lip repairs, lip butters, lip conditioners, and lip jellies.

	There are lip balm bloggers (so many bloggers!), lip balm chat rooms, and posting sites, through which flows a seemingly endless exchange of lip balm lore, product feedback, and shopping tips.

	Oh, and let us not forget Lip Balm Anonymous. That’s right. There is a site for the addicted.

	Well, we know now. A word to the retailers among us:

. Lip Vibrance provides a touch of lasting color and shimmer, plus moisturization and protection for dull, lackluster lips. “Your lips' complexion will have an even tone that radiates health,” says the product literature. 

his balm goes beyond effective protection and hydration to feed lips with exceptional nutrients and antioxidants, in an effective, comfortable formula that is a unique blend of olive and grapeseed oils, goji extract, vitamin E, and essential minerals that protects lips and maintains a healthy moisture balance, “for exceptionally healthy lips inside and out.”

		Among other lip care offerings from Blistex are Herbal Answer, Daily Conditioning Treatment, Medicated Lip Ointment, Five Star Lip Protection, Cold & Allergy Lip Soother, Moisture Melt, Deep Renewal, Silk & Shine, Complete Moisture, Lip Medex, and Medicated Lip Balm.

Revitalizing Lip Balm with Blueberry and Dark Chocolate.

 “A dessert combo to delight your lips,” this 100% natural revitalizing lip balm is infused with the antioxidant properties of blueberry seed oil and cocoa powder, and blended with natural butters and oils to renew and reveal beautiful, healthy-looking lipsâ¨. 100% natural.

. “Fresh fruit balms that are always in season” combine beeswax to naturally help condition lips with beneficial nutrients and "amazing flavors" for lips that "feel soft and taste great." The 4-pack contains R

		eplenishing Lip Balm with Pomegranate Oil, Refreshing Lip Balm with Pink Grapefruit, Rejuvenating Lip Balm with Acai Berry, and Nourishing Lip Balm with Mango Butter.

		Burt’s also offers Ultra Moisturzing Lip Treatment, Ultra Conditioning Lip Balm with Kokum Butter, Beeswax Lip Balm with Vitamin E and Peppermint, Honey Lip Balm with Vitamin E, Island Lip Balm with Passion Fruit, Soothing Lip Balm with Eucalyptus and Menthol, and nine shades of Tinted Lip Balm.

. An eight-product “slim-stick lip balm line” ... presents a fashion-forward exterior” in eight separate package designs, each named to evoke a different style, such as Chic (houndstooth), Fab ("a groovy retro look"), Adventurous (leopard print), and Whimsical (art deco).

	“Lip care is an important component of a daily beauty regimen and consumers need a product they can rely on that protects and serves as an important foundation,” said Paul Woelbing, president of Carma Laboratories, Inc., in a prepared statement. “The goal of the new Carmex Moisture Plus line is to offer our consumers a hard-working lip balm line that represents and reflects their unique style.”

	The balm itself is formulated with an ultra-hydrating proprietary technology and features aloe, vitamin E, and broad spectrum SPF 15 sunscreen.

	At its website, Carmex offers “The Little Lip Book” (mycarmex.com/assets/pdf/LipBook.pdf‎), written by an independent group of clinicians dsescribed as uninvolved with product creation or marketing. It’s a highly informative 35-page guide to lip health and lip care that is likely to come in handy when patients turn up with arcane lip-related questions.

Its silky, sheer color and a conditioning formula containing a triple-berry antioxidant complex of acai, goji, and aronia actually improves the healthy look, softness, and smoothness of lips over time, says the product literature. Available in 14 alliteratively named shades that range from neutral through pink, mauve,and plum.

 It provides hydsration, instant, soothing relief and a high-gloss shine. A unique hydragel formula contains cucumber, chamomile, and glycerin for intense moisturization. Available in nine tightly themed shades: Shimmer, Glimmer, Glisten, Shine, Gleam, Sparkle, Sheen, Glaze, and Glow.

 This product helps make lips softer, rosier, and healthier-looking, even after it is removed, says the literature. Its sheer tinted balm, formulated with Neutrogena’s exclusive ion2complex, instantly moisturizes lips, improving their texture and leaving them looking fuller and more defined. Available in six sheer tints: Sheer Shimmer, Healthy Blush, Sunny Berry, Petal Glow, Soft Caramel, and Fresh Plum.

 A newly launched hybrid formula with the pigment and shine of a gloss but the texture and moisturizing properties of a lip balm. According to Almay, “Shiny color drenches lips with 2x hydration as lip-loving conditioners provide 194% more moisture for softer, smoother lips over time.” The 10 available shades are: just plum good,  nudetrients (sic), apple a day, lilac love, pink pout, blooming balm, cantaloupe cream, rosy lipped, apricot pucker, and truffle kiss, all noted in refreshing lower case. Almay manufactures cosmetics for sensitive skin; its formulas are hypoallergenic and dermatologist-tested

	Last but not least, a racy new product line with a '70s theme. According to the website, all its balms are 100% natural and made with organic extra virgin olive oil, organic palm oil, organic hemp seed oil, beeswax, rosemary extract, and vitamin E, with mineral tints derived from mica, titanium dioxide, and iron oxide. But It’s the product names (not to mention the illustrations: 

) that will really grab a certain passionate lip-balm demographic: Sweet Baby Ginger, Wild Mountain Honey, Juicy Melons, Huge Cucumber, and Hot Chocolate Love.

	Balm Chicky products are packaged in a tube capped at both ends, so that a user can balm a pal with “The Friend End,” leaving the other end sanitary and germ-free (once per tube, anyway).

A few randomly selected websites giving it up for lip balm

	Three camphor-free user-friendly flavors

http://www.moogoo.ie/edible-lip-balm.html

http://www.onegreenplanet.org/lifestyle/vegan-beauty-reviews-favorite-things-lip-balms/

http://tastespace.wordpress.com/2013/03/02/the-best-vegan-lip-balms/

	Consumers vote their faves up and their hates down

http://www.ranker.com/list/best-lip-balm-brands/makeup-tips

http://www.apetogentleman.com/top-10/top-10-lip-balms-for-men/

http://www.amodelrecommends.com/2012/01/09/little-pots-of-luxury/

	Tips on what to look for and what to avoid 

http://blog.sampleroom.ph/2013/07/love-lipbalms-addicted-to-lipbalms/

	Design your own company logo giveaway item; 100 tubes with custom-printed label, $49.

	“The original site about lip balm addiction”