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Perrigo receives FDA approval for generic Astepro

BY Ryan Chavis

DUBLIN — Perrigo on Monday announced that it received approval from the Food and Drug Administration for azelastine hydrochloride nasal spray (0.15%), a generic version of Astepro.

The prescription medicine is indicated for people ages 12 years and older and is used to treat nasal symptoms brought on by seasonal allergies or environmental irritants. Annual sales for the drug were approximately $97 million, according to Symphony Health Solutions

"This approval is another example of our investment in new products and expansion of our extended topical product portfolio. We are pleased to be the partner of choice with Impax on this important product opportunity. As always, Perrigo is committed to making quality health care more affordable for our customers," said Joseph C. Papa, Perrigo’s chairman and CEO.      

The company’s abbreviated new drug application involves contributions from both Perrigo and Impax Labs; the two companies will share certain costs and benefits of the product.

 

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CHPA files comments to FDA regarding OTC Drug Review

BY Michael Johnsen

WASHINGTON — The Consumer Healthcare Products Association on Friday filed comments to the Food and Drug Administration in response to the agency’s Notice of Public Hearing and Request for Comments on the Over-the-Counter Drug Monograph System, also referred to as the OTC Drug Review.

CHPA’s comments underscored its support for the FDA’s re-examination of the system in an effort to complete the OTC Drug Review. CHPA believes this can best be accomplished by utilizing and reforming mechanisms the FDA already has in place.

“The way over-the-counter products are currently regulated has been demonstrably effective for more than 40 years,” said Scott Melville, CHPA president and CEO. “We can improve upon it without undermining a sensible system that has served consumers well.”

In particular, CHPA offered the following suggestions for streamlining the process to promptly resolve the tentative final monographs:

  • Accelerating completion of  the tentative final monographs through clearer communication on what data/information is needed to complete them;
  • Recognizing FDA has ample authority to address emerging safety issues both within and outside of rulemaking, regardless of whether a monograph is final or tentative final;
  • Prioritizing and breaking TFMs into smaller parts to finalize what can be finalized without waiting for the whole; and
  • Accelerating completion of TFMs through a single point leader outside of Office of New Drugs.

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Real Techniques unveils marketing program featuring Pixiwoo YouTube beauty stars

BY Antoinette Alexander

GURNEE, Ill. — Real Techniques, a Paris Presents brand, is calling all beauty lovers to reveal their inner artist through a sponsored marketing program with Allure magazine.  

They can try their hand at recreating a makeup look designed by Pixiwoo YouTube beauty stars Sam and Nic Chapman for a chance to win an in-person makeover by the sisters. The look — a bronze smoky eye — was inspired by the trending colors of the season and created using Real Techniques makeup brushes.  

One participant will win an in-person makeover with the sisters for them and a friend, including a two-night hotel stay. Two runners-up will receive a virtual makeover with the sisters, as well as an assortment of makeup and the full collection of Real Techniques makeup brushes, and 15 will walk away with a prize package of assorted Real Techniques products. Submissions will be accepted through June 30.

Real Techniques makeup brushes are designed with the expertise of the sisters, who together have worked fashion shows, editorials and celebrity shoots as professional makeup artists. Their YouTube how-to beauty channel, Pixiwoo, has 196 million video views and counting.  Each brush features super-soft bristles and an extended aluminum ferrule for light and easy application.  A color-coded system corresponds to the key steps of makeup application so you can create a base (orange), enhanced eyes (purple), and finish (pink) like a pro.

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