Impax Laboratories, Inc. (NASDAQ: IPXL) announced on Monday morning that it secured final U.S. Food and Drug Administration approval and an AB therapeutic equivalent rating for a generic version of Concerta (methylphenidate hydrochloride) extended-release tablets USP CII, 18, 27, 36 and 54 mg.
Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. The tablets had U.S sales of approximately $1.8 billion, according to IMS Health for the 12 months ending May 2017.
Impax traded up 9.701% during trading on Monday, hitting $18.375. The stock had a trading volume of 1,211,690 shares. Impax Laboratories has a 52-week low of $7.75 and a 52-week high of $31.85. The company has a 50-day moving average price of $15.78 and a 200-day moving average price of $13.40. The company’s market cap is $1.32 billion.
Impax last released its quarterly earnings data on Wednesday, May 10th. The specialty pharmaceutical company reported $0.11 earnings per share for the quarter, missing analysts’ consensus estimates of $0.12 by $0.01. The firm had revenue of $184.40 million during the quarter, compared to analysts’ expectations of $193.17 million. Impax Laboratories had a negative net margin of 71.50% and a positive return on equity of 7.71%. The firm’s quarterly revenue was down 18.2% on a year-over-year basis. During the same period in the previous year, the firm posted $0.43 EPS. Equities research analysts forecast that Impax will post $0.65 EPS for the current year.