Perrigo announces FDA final approvals for generic equivalents to Derma-Smoothe/FS scalp, body oils
ALLEGAN, Mich. — Perrigo Co. today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil. Perrigo expects to begin shipments of both products next month.
Derma-Smoothe/FS Scalp Oil (fluocinolone acetonide scalp oil, 0.01%) and Derma-Smoothe/FS Body Oil (fluocinolone acetonide topical oil, 0.01%) are indicated for the topical treatment of atopic dermatitis in adult patients and the topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks. Both products have combined annual sales of approximately $25 million, as measured by Symphony Health Solutions.
Perrigo’s chairman, president and CEO Joseph C. Papa stated, "This is another example of our Rx team’s commitment to launching difficult to manufacture topicals, lotions and foams. We are excited to begin shipments of these products and are dedicated to making quality health care more affordable for all consumers around the globe."
From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Co. has grown to become a leading global provider of quality, affordable healthcare products, the company stated. Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients.
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NASPA event highlights challenges, opportunities
All the issues and trends impacting retail pharmacy professionals and the industry they serve filter through the 50 state pharmacy associations like currents that feed a larger stream. So the summer meeting of the National Alliance of State Pharmacy Associations served up a laundry list of the most nagging challenges and most promising opportunities facing pharmacy leaders in the coming years, as they confront new reimbursement paradigms, current regulatory hurdles, dramatically new health delivery models and the growing demand for a more patient-centered and more engaged form of pharmacy practice.
Over an uninterrupted, four-and-a-half-hour dialogue Saturday afternoon, dozens of state pharmacy association executives and industry leaders grappled with a wide range of topics that define the challenges and potential facing pharmacy, including:
- Emerging models of healthcare delivery spurred by health reform and the new evidence-based reimbursement paradigm;
- Medication adherence and the role that medication synchronization could play;
- Federal supply chain legislation to establish a nationwide track-and-trace system; and
- New efforts to establish and document the value of pharmacist interventions and new collaborative-practice models.
The meeting marked a new chapter in the relationship between NASPA and the National Association of Chain Drug Stores, NASPA president Ron Fitzwater indicated. “This is the first time we’ve done this, and we’re looking forward to continuing the relationship in the future. It’s a great opportunity to get state pharmacy associations more formally involved with some very important partners,” Fitzwater said, who is also CEO of the Missouri Pharmacy Association.
Keys to finding financing
Suppose an emerging vendor has a product and retail buyers have expressed interest. The only problem is, it doesn’t have the funding it needs
That’s where Intersection Capital comes in. The Los Angeles-based firm, headed by Oren Klaff, helps companies obtain growth financing. “When companies start to create sales, all sorts of interesting things happen,” Klaff said Saturday at a workshop-style presentation.
Klaff emphasized that investors don’t care about the details of a company’s product. That may sound counterintuitive, but to investors, what matters is whether there’s a market and whether the product will thrive in that market.
“Your job is not to explain the product; it is to provide certainty that the future revenues you described are going to happen,” Klaff said. To accomplish this, Klaff suggested companies have a “pitch deck,” consisting of a brief description of the company’s current situation called a “window sticker,” the “big idea” behind the product, the financial opportunity, highlights about the company, forward-looking financials, what the company will do with the money and whom to call.