FDA approves ANI’s morphine sulfate oral solution
The Food and Drug Administration has approved ANI Pharmaceuticals’ morphine sulfate oral solution, 10 mg/5 ml, 20 mg/5 ml and 100 mg/5 ml. The Baudette, Minn.-based company’s generic is indicated to manage acute and chronic pain severe enough to require an opioid analgesic for which alternative treatments are inadequate.
ANI executives said that this approval marks the sixth that the company has received for a product from its internally developed pipeline. The company said it expects to ship the product — whose annual market size QVIA data pegs at around $17 million — in the near future.
“We are pleased to announce the approval of this internally developed generic product, which leverages both our liquid manufacturing and controlled substance capabilities,” ANI president and CEO Arthur Przybyl said. “In addition to the standard packaging formats, we intend to launch the product in a unit dose configuration.”
Q&A: Alok Sonig highlights Dr. Reddy’s efforts to improve access to medicine
Alok Sonig said that Princeton, N.J.-based Dr. Reddy’s has made its mark by offering affordable and innovative medicines to people who need them. Drug Store News sat down with Sonig, the company’s CEO of developed markets, to discuss upcoming launches from Dr. Reddy’s and the industry overall.
Drug Store News: Tell us about Dr. Reddy’s and its history.
Alok Sonig: Dr. K. Anji Reddy founded Dr. Reddy’s in 1984 with a mission to ensure that good health can be a reality for everyone. What started off as a small company eventually evolved into the major global pharmaceutical presence it is today.
We are proud of the many milestones that make up our history. From being the first Indian pharma company to export Norfloxacin and Ciprofloxacin to Europe and the Far East to becoming the first
Asia Pacific pharmaceutical company, outside Japan, to be listed on the New York Stock Exchange.
Importantly, Dr. Reddy’s has never lost sight of its founding principle: to provide patients with access to affordable and innovative medicine.
DSN: How about now? The company is introducing many new items this year. Tell us about them.
AS: Dr. Reddy’s has a deep-rooted belief that “Good Health Can’t Wait.” As a company, we focus on bringing affordable medicines within reach of patients who need them.
Currently, we are awaiting FDA approval or feedback on more than 100 ANDAs. Additionally, we expect to launch nearly 20 new products in the U.S. market in the next 12-to-18 months. Many of these products are expected to be complex or difficult to make, and they will fall in the limited-competition space. These launches are in multiple disease categories, including, but not limited to, anti-addiction, multiple sclerosis and female contraception.
We are also growing significantly in the oncology space, with the introduction of several complex injectable products. To prepare for this, we are developing great relationships with oncology treatment centers and hospitals.
DSN: How are you supporting these products to the trade?
AS: We have a very close relationship with our trade partners and are excited about the prospect of bringing new products to our customers by strengthening our relationship with them.
As part of our strategy, a key area of focus is building a reliable and flexible supply chain for our products. This commitment allows us to handle situations, like demand surges, by helping our trade partner serve patients with uninterrupted supply of medicines. In fact, during the past year, we were awarded the Cardinal Health Supply Chain Excellence Award. It was truly an honor from an outstanding supplier.
DSN: The generics category is evolving at retail. How do retailers maximize their profits from this category?
AS: Although our generic prescription products are dispensed by pharmacy only, we have a strong and growing OTC division that caters to consumers through all major retailers. We currently market OTC products in various segments, including allergy, antacid, analgesia and smoking cessation.
In fact, we recently launched Levocetirizine dihydrochloride tablets in the U.S. market. This generic version of Xyzal was a first-to-market launch for Dr. Reddy’s.
DSN: How does the future look?
AS: Dr. Reddy’s is well positioned for sustained, profitable growth given our strong base business and proven capability in complex generics, with strategic investments in research and development for proprietary products and biologics. Our core business performance remains strong. Our development levers are proven, vigorously executed and continue to deliver. We will continue to make strategic investments for long-term, sustainable growth, while continuing to explore selective business integration and opportunities to augment expansion.
Alok Sonig is CEO of developed markets at Dr. Reddy’s
Lupin’s generic AndroGel gets tentative approval
The Food and Drug Administration has granted Lupin tentative approval for its generic AndroGel (testosterone gel, 1.62%). The drug is indicated as a replacement therapy in males for conditions associated with deficiency or absence of endogenous testosterone.
Lupin’s generic AndroGel will be available in a dosage strength of a 20.25 mg/1.25 gm actuation. The drug had U.S. sales of $956.9 million for the 12 months ended January 2018.