SOUTH BELOIT, Ill., April 30, 2013 (GLOBE NEWSWIRE) -- TAGI Pharma, Inc., a specialty pharmaceutical company and subsidiary of Precision Dose, Inc., announced today the signing of an exclusive marketing rights agreement to market and sell the approved ANDA product, Alendronate Sodium Oral Solution, 70mg/75mL in the United States and its territories, possessions and protectorates.
Alendronate Sodium Oral Solution, 70mg/75mL is the only FDA approved generic alternative to Merck & Co., Inc.'s FOSAMAX® (alendronate sodium) oral solution product. Alendronate Sodium Oral Solution is a bisphosphonate, and indicated for the (1) treatment of osteoporosis in postmenopausal women, and (2) treatment to increase bone mass in men with osteoporosis. Alendronate Sodium Oral Solution is contraindicated in patients (1) with abnormalities of the esophagus which delay emptying such as stricture or achalasia, (2) with inability to stand/sit upright for at least 30 minutes, (3) at increased risk of aspiration, (4) with hypocalcemia, (5) with hypersensitivity to any components of this product. (See the accompanying prescribing information for additional safety and product information.)
Thomas Anderson, Executive President and responsible for TAGI's Business Development activities, said, "This agreement represents an additional step forward in the implementation of TAGI Pharma's business plan to bring differentiated products to the marketplace, utilizing an aggressive business development initiative to license, acquire and co-develop products." Kenny Harrington, Vice President of Sales and Marketing of TAGI Pharma, said "The Alendronate Sodium Oral Solution product addresses unmet needs in the market for a liquid Alendronate Product, and complements TAGI's strategy to provide unique products to underserved customers. We expect to have the Alendronate Sodium Oral Solution product available for shipment to our customers in May, but our website (www.tagipharma.com) will be updated with the exact date as we get closer to launch."
About TAGI Pharma, Inc. and Precision Dose, Inc.
"TAGI Pharma, Inc. was established to target the generic retail market," said Thomas Anderson, "and our product selection for TAGI Pharma is focused on higher barriers to entry and limited competition, where there are market expansion opportunities in the retail market, as well as the non-retail sector currently being serviced by Precision Dose."
Precision Dose was established in 2003, and continues to work with the products of prescription and non-prescription liquid manufacturers, as well as its own products, to add value through its unique unit dose delivery systems, servicing the hospital and long term care markets. "With its unique line of liquid unit dose products, Precision Dose continues to expand market share by meeting customers' needs to eliminate dispensing errors, improve inventory control and achieve cost containment. We are uniquely positioned in the marketplace, leveraging the customer relationships of both companies, and thereby optimizing the market opportunities for our products," said Robert Koopman, President and CEO of both TAGI Pharma and Precision Dose, Inc.
BRIEF SUMMARY
This brief summary does not include all the information needed to use Alendronate Sodium Oral Solution safely and effectively. Please see package insert for full prescribing information for Alendronate Sodium Oral Solution.
ALENDRONATE SODIUM ORAL SOLUTION
70 mg/75 mL
DESCRIPTION
Each bottle of Alendronate Sodium Oral Solution contains 91.35 mg of alendronate monosodium salt trihydrate, which is the molar equivalent to 70 mg of free acid.
INDICATIONS
Alendronate Sodium Oral Solution is a bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis.
DOSAGE AND ADMINISTRATION
For the above indications, the recommended dosage is one bottle of 70 mg oral solution once weekly.
Alendronate Sodium Oral Solution must be taken at least one-half hour before the first food, beverage, or medication of the day, followed by at least 2 oz of plain water. Alendronate Sodium Oral Solution should only be taken upon arising for the day. Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate Sodium Oral Solution should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences.
CONTRAINDICATIONS
- Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
- Inability to stand or sit upright for at least 30 minutes
- Do not administer Alendronate Sodium Oral Solution to patients at increased risk of aspiration.
- Hypocalcemia
- Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported.
WARNINGS AND PRECAUTIONS
Upper Gastrointestinal Adverse Reactions
Alendronate Sodium Oral Solution, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Alendronate Sodium Oral Solution is given to patients with active upper gastrointestinal problems. Esophageal adverse experiences have been reported in patients receiving treatment with oral bisphosphonates. In some cases these have been severe and required hospitalization.
Mineral Metabolism
Hypocalcemia must be corrected before initiating therapy with Alendronate Sodium Oral Solution. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy with Alendronate Sodium Oral Solution
Musculoskeletal Pain
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates that are approved for the prevention and treatment of osteoporosis. Discontinue use if severe symptoms develop.
Osteonecrosis of the Jaw
Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates. Known risk factors for osteonecrosis of the jaw include invasive dental procedures, diagnosis of cancer, concomitant therapies, poor oral hygiene, and co-morbid disorders.
Atypical Subtrochanteric and Diaphyseal Femoral Fractures
Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients.
Renal Impairment
Alendronate Sodium Oral Solution is not recommended for patients with creatinine clearance <35 mL/min.
ADVERSE REACTIONS
The most frequently observed adverse reactions with Alendronate Sodium Oral Solution administration during clinical trials include abdominal pain, musculoskeletal pain, nausea, dyspepsia, constipation, diarrhea, flatulence, headache, and acid regurgitation. Other adverse reactions include allergic reactions, rash, pruritis, and rarely severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
To report SUSPECTED ADVERSE REACTIONS, contact Roxane Laboratories, Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Calcium Supplements/Antacids
Co-administration of Alendronate Sodium Oral Solution and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of Alendronate Sodium Oral Solution. Therefore, patients must wait at least one-half hour after taking Alendronate Sodium Oral Solution before taking any other oral medications.
Aspirin
In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of Alendronate Sodium Oral Solution greater than 10 mg and aspirin-containing products.
Nonsteroidal Anti-Inflammatory Drugs
Alendronate Sodium Oral Solution may be administered to patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with Alendronate Sodium Oral Solution.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C:
There are no studies in pregnant women. Alendronate Sodium Oral Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Nursing Mothers
It is not known whether alendronate is excreted in human milk. Caution should be exercised when Alendronate Sodium Oral Solution is administered to nursing women.
Pediatric Use
Alendronate Sodium Oral Solution is not indicated for use in pediatric patients.
Geriatric Use
No overall differences in efficacy or safety were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Renal Impairment
Alendronate Sodium Oral Solution is not recommended for patients with creatinine clearance <35 mL/min.
Hepatic Impairment
No dosage adjustment is necessary.
STORAGE AND HANDLING
Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Do not freeze.
10005270/01 Revised February 2013
© RLI, 2013