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Fertile women should supplement diets with folic acid, study finds

BY Michael Johnsen

To help mitigate the risk of autistic traits in children exposed to antiepileptic drugs in utero, women may benefit from folic acid supplementation before they get pregnant, according to a late December article published in JAMA Neurology. Fertile women using antiepileptic drugs should take folic acid supplements continuously, the study concluded.

[quote-from-article] “Supplementing with folic acid by women who are pregnant, or capable of becoming pregnant, has proven essential to reduce neural tube birth defects in babies, and this new study demonstrates the potential for additional benefits of continuous folic supplementation," commented Andrea Wong, vice president, scientific and regulatory affairs for the Council for Responsible Nutrition. "Although this study points to the reduction of autistic traits associated with folic acid supplementation in a specific population — women taking antiepileptic drugs — it underscores the importance for all women capable of becoming pregnant to supplement with folic acid, too. The recommendation for all women of childbearing age to supplement with folic acid is supported by the U.S. Government, the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, and the American Academy of Pediatrics, and should be heeded to promote the health and wellbeing of future children."

In addition to reinforcing the benefits of folic acid supplementation, the study raises the importance of an open dialogue between patients and their doctors or pharmacists. Some pharmaceutical drugs can have interactions with certain dietary supplements. And other medications can create nutrient depletions or side effects that can be mitigated or offset with careful use of dietary supplements. Both occurrences illustrate the need for patients to discuss candidly both their medication and supplement regimens with their doctors or other healthcare practitioners.

According to CRN, folic acid is only one of many essential nutrients that are necessary for a healthy pregnancy. Well-established science has demonstrated that adequate intakes of iodine, choline, omega-3 fatty acids and iron are also critical during pregnancy and help lead to healthier babies.

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FDA approves Lupin’s generic Dovonex Scalp Solution

BY DSN STAFF

The Food and Drug Administration has approved Lupin’s generic of Leo Pharmaceutical Products’ Dovonex Scalp Solution (calcipotriene topical solution, 0.005%). The product is indicated for the topical treatment of moderately severe psoriasis on the scalp.

According to IQVIA data, the product had U.S. sales of roughly $5.9 million for the 12 months ended October 2017.

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ANI buys 4 products from AstraZeneca

BY David Salazar

ANI Pharmaceuticals has acquired four potential new drugs from AstraZeneca, the Baudette., Minn.-based company announced recently. The company acquired the new drug applications and U.S. marketing rights to Atacand, Atacand HCT, Arimidex and Casodex for $46.5 million in cash, royalties and sales-based milestones.

“This acquisition complements our brand and generic strategies and further expands and diversifies our commercial portfolio,” ANI president and CEO Arthur Przybyl said. “Importantly, ANI has the capability to manufacture and package all of the products at our containment facility in Baudette, Minn. The addition of these assets will be material to our revenue and EBITDA in 2018, and we plan to provide financial guidance for 2018 at the time of our next regularly scheduled earnings announcement.”

Atacand is indicated to treat hypertension and heart failure; Atacand HCT is indicated to treat hypertension; Arimidex is indicated to treat certain types of breast cancer in postmenopausal women; and Casodex is indicated as a combination therapy in certain types of carcinoma of the prostate, while its 150-mg dosage strength is not yet approved for use. The four drugs collectively generated $19 million for the 12 months ended October 2017, according to IQVIA data.

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