Teva intros authorized Estrace Cream generic
Teva has launched its authorized generic of Allergan’s Estrace Cream (estradiol vaginal cream, 0.01%). The addition to Teva’s women’s health portfolio is indicated to treat moderate-to-severe symptoms of vulvar and vaginal atrophy resulting from menopause.
The drug had U.S. sales of roughly $426 million for the 12 months ended August 2017, according to IQVIA data.
Amazon claims large portion of U.S. e-commerce sales in 2017
The online giant claimed an estimated 44% of all U.S. e-commerce sales in 2017, according to a study from One Click Retail. Amazon also accounted for 4% of the country’s total retail sales for the year — approximately $200 billion, revealed the study, “Amazon Year in Review: The 5 Biggest Trends of 2017.
The product category that accounted for the most sales last year on Amazon was consumer electronics, which generated more than $8 billion. The online giant’s home & kitchen and publishing divisions followed behind with $5.5 billion and $5 billion in sales respectively. The sports & outdoors segment came in fourth with $4 billion in sales.
When it comes to Amazon’s fastest going product categories, luxury beauty lead the charge with a 47% year-over-year growth ($400 million in sales). The pantry category had 38% growth with $500 million in sales. Amazon’s grocery and furniture categories each posted 33% year-over-year growth, and $1.5 billion in sales, respectively.
In addition to these gains, 2017 marked additional wins for the e-retailer. After spending 2016 quietly building its automated marketing system, and then adding major system upgrades in 2017, Amazon now has a sophisticated search platform that includes a broad range of keywords for mobile, desktop, and/or app users. It also integrates with email marketing and vendor-powered coupons.
Today, over 50% of product searches begin on Amazon – and only Amazon has the ability to convert click-throughs to sales. With these added benefits and some killer ROI metrics, many brands have started taking their search budgets out of Google and Facebook and putting their money on Amazon, according to the report.
Sales of consumables exploded in 2017 with over 35% annual growth. These sales were bolstered by Amazon’s acquisition of Whole Foods, and what is now the online giant’s second-largest private brand: 365 Everyday Value — a category with over $10 million in estimated 2017 sales, the report said.
“Ultimately, success – for both Amazon itself and for brands that sell through the platform – comes down to knowing your audience,” said Spencer Millerberg, CEO, One Click Retail. “It’s clear that Amazon catered to the right crowd in 2017, and the brands that correctly understood who their products were for – and who they were most useful to – are the ones that had a very good year.”
FDA unveils draft guidance, MAPP on ANDA submissions
The Food and Drug Administration is moving full speed ahead into the new year, releasing two documents Wednesday as part of its ongoing Drug Competition Action Plan. The documents are aimed at making the generic approval process speedier and reducing the number of review cycles for abbreviated new drug applications, or ANDAs.
The first document is a draft guidance for the industry called “Good ANDA Submission Practices,” which outlines typical deficiencies in ANDA submissions that can delay approval. The agency noted that it takes on average foru cycles for an application to be approved, in several cases because the application lacks necessary information and not because the product doesn’t meet safety standards.
“These multiple cycles of review are costly and inefficient. They require a great deal of additional, avoidable work by both agency staff and the applicant and can delay the entry of generic competition,” FDA commissioner Scott Gottlieb said. “Through today’s guidance, as well as others from the agency, we can achieve one of the FDA’s key goals in 2018 — to reduce the number of review cycles — by helping applicants avoid these common deficiencies that lead to review delays and application cycling.”
Alongside the draft guidance, the FDA released a Manual of Policies and Procedures, or MAPP, called “Good ANDA Assessment Practices” that outlines for FDA staff the agencies practices for evaluating applications. Gottlieb said the MAPP formalized a streamlined assessment process and introduces templates to make each cycle more efficient. The MAPP also establishes necessary communication between the FDA and a company, requiring the FDA provide more details about an application’s deficiency, outline how to provide more information and offer more details on what new info should be provided in a subsequent application cycle.
“As with the draft guidance on submission practices, this MAPP should reduce the number of subsequent cycles that applications must undergo, and avoid the cycling of applications that is a significant cause of the delays in generic approvals,” Gottlieb said. “The MAPP also clarifies the roles and responsibilities of different review disciplines to reduce inconsistencies as well as duplicative and unnecessary work. This will greatly increase the efficiency and effectiveness of the agency’s generic drug review teams.”
Gottlieb said that efforts the agency implemented in 2017 have begun to yield results, with November marking the highest number of generic approvals in a single month in the agency’s history. Gottlieb promised continued efforts in the generics space as part of the Drug Competition Action plans, including efforts to accelerate the entry of complex generics and reduce the use of delay tactics by certain manufacturers.
“It’s part of our public health mission to ensure safe, effective, quality medicines are available to the patients that need them,” Gottlieb said. “Most importantly, the FDA will continue to be the gold standard for approval of all drug applications, and we will make sure that consumers can continue to trust in that assessment.”