FDA sets advisory committee meeting for potential switch of Merck’s Singulair Allergy tablets
SILVER SPRING, Md. — The Food and Drug Administration on Friday announced a meeting of the Nonprescription Drugs Advisory Committee on May 2 to discuss the potential switch of Merck’s Singulair Allergy tablets.
The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older.
Prescription-only Singulair is currently used to treat outdoor allergies that happen part of the year (seasonal allergic rhinitis) in adults and children ages 2 years and older, and indoor allergies that happen all year (perennial allergic rhinitis) in adults and children ages 6 months and older.
As a prescription remedy, Singulair is also indicated to prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older, as well as to prevent exercise-induced asthma in people 6 years of age and older. However, there is nothing suggesting that OTC Singulair Allergy will be indicated to treat or prevent any asthma symptoms.
Greenstone announces generic Caduet
PEAPACK, N.J. — Greenstone, a generic pharmaceutical subsidiary of Pfizer, announced the introduction of amlodipine besylate/atorvastatin calcium tablets to its roster of products. The drug is the authorized generic versions of Caduet.
The drug is used for the treatment of high blood pressure (hypertension) and high cholesterol (hyperlipidemia). Greenstone’s amlodipine besylate/atorvastatin calcium tablets are available in the following dosage strengths: 2.5 mg/10 mg x 30; 2.5 mg/20 mg x 30; 2.5 mg/40 mg x 30; 5 mg/10 mg x 30; 5 mg/20 mg x 30; 5 mg/40 mg x 30; 5 mg/80 mg x 30; 10 mg/10 mg x 30; 10 mg/20 mg x 30; 10 mg/40 mg x 30; 10 mg/80 mg x 30; 5 mg/10 mg x 500; 5 mg/20 mg x 500; 5 mg/40 mg x 500; 10 mg/10 mg x 500; 10 mg/20 mg x 500; 10 mg/40 mg x 500.
Prestige Brands acquires Hydralyte to add to its Australian portfolio
TARRYTOWN, N.Y. — Prestige Brands on Tuesday announced the signing of a purchase agreement for the acquisition of Hydralyte in Australia and New Zealand from the Hydration Pharmaceuticals Trust of Victoria, Australia. The acquisition is expected to close, subject to customary closing conditions, during the company’s first quarter of fiscal 2015, which began on April 1, 2014.
"Hydralyte is a strong, strategic addition to our portfolio," stated Matthew Mannelly, Prestige CEO. "It is a high growth, market-leading OTC brand with a name synonymous with oral rehydration among both consumers and healthcare professionals. Hydralyte strengthens and complements our portfolio, is expected to double the revenues of our Australian subsidiary and is another step closer to our stated goal to grow our business in the Austral-Asia region to $100 million.”
According to Mannelly, the acquisition is projected to double the annual revenues of Care Pharmaceuticals, Prestige’s subsidiary in Australia, to approximately $50 million (AUD) for fiscal 2015, and is expected to be accretive to Prestige’s earnings per share for fiscal 2015, exclusive of transaction, integration and purchase accounting items. Prestige acquired Care Pharmaceuticals in July 2013.
“Hydralyte is well-positioned to benefit from both Care and Prestige’s core competencies in brand building and innovation. Care’s strong management team under the leadership of Malcolm Yesner has a long track record of successful brand building and driving sales growth by focusing on consumer needs, innovation and new products,” Mannelly said. “In the nine months since its acquisition, Care has already successfully integrated Prestige’s Murine eye care brands into its portfolio, and is now well-positioned to integrate the Hydralyte acquisition. We look forward to continuing to build and expand our strong portfolio in the fast-growing Austral-Asia region.”
Hydralyte is the leading over-the-counter brand in oral rehydration in Australia and New Zealand, and will be marketed and sold through Care Pharmaceuticals, Prestige noted in a release. Hydralyte is available in pharmacies in multiple forms and is indicated for oral rehydration following diarrhea, vomiting, fever, heat and other ailments.
Financial terms of the acquisition have not been disclosed.