Content about New Drugs & OTCs

April 3, 2014

First Aid Shot Therapy on Wednesday announced the launch of First Aid Shot Therapy Upset Stomach.

SEATTLE — First Aid Shot Therapy on Wednesday announced the launch of First Aid Shot Therapy Upset Stomach. Upset Stomach is the second variant to be launched in the F.A.S.T. range of products and it is formulated to relieve upset stomach symptoms. 

April 2, 2014

AZO Products, a urinary and vaginal health brand for women, announced the launch of AZO Bladder Control with Go-Less. The product serves as a supplement to prescriptions and over-the-counter options and helps optimize normal bladder activity and bladder strength, the company said.

CROMWELL, Conn. — AZO Products, a urinary and vaginal health brand for women, announced the launch of AZO Bladder Control with Go-Less. The product serves as a supplement to prescriptions and over-the-counter options and helps optimize normal bladder activity and bladder strength, the company said.

AZO Bladder Control with Go-Less contains pumpkin seed extract, which helps with maintaining bladder muscle function, along with soy isoflavones, which help maintain strong bladder muscles.

April 2, 2014

Greer Labs, a developer and provider of allergy immunotherapy products and services, announced that the Food and Drug Administration has approved Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass mixed pollens allergen extract) sublingual allergy immunotherapy tablet.

LENOIR, N.C. — Greer Labs, a developer and provider of allergy immunotherapy products and services, announced that the Food and Drug Administration has approved Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass mixed pollens allergen extract) sublingual allergy immunotherapy tablet.

April 2, 2014

Sandoz on Tuesday announced the U.S. market introduction of its calcipotriene and betamethasone dipropionate ointment, the first generic version of Leo Pharma’s Taclonex Ointment.

PRINCETON, N.J. — Sandoz on Tuesday announced the U.S. market introduction of its calcipotriene and betamethasone dipropionate ointment, the first generic version of Leo Pharma’s Taclonex Ointment.

Calcipotriene and betamethasone dipropionate ointment is a vitamin D analogue and corticosteroid combination product indicated for the topical treatment of psoriasis vulgaris in adults 18 years and older.

Psoriasis affects approximately 2% of the U.S. population. Plaque psoriasis is the most common form of the condition. 

April 1, 2014

Prasco Labs on Tuesday announced that it has signed a marketing and distribution agreement with Eli Lilly and Co. to market the authorized generic version of Evista (raloxifene hydrochloride tablets), 60 mg strength, in the United States.

CINCINNATI — Prasco Labs on Tuesday announced that it has signed a marketing and distribution agreement with Eli Lilly and Co. to market the authorized generic version of Evista (raloxifene hydrochloride tablets), 60 mg strength, in the United States.

April 1, 2014

Teva Pharmaceuticals on Tuesday announced the introduction and availability of Raloxifene hydrochloride tablets, USP.

JERUSALEM — Teva Pharmaceuticals on Tuesday announced the introduction and availability of Raloxifene hydrochloride tablets, USP. This product is AB rated and bioequivalent to Evista tablets.  

Raloxifene hydrochloride tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. 

Teva was first to file, making the product eligible for 180 days of marketing exclusivity.

March 31, 2014

Just days after the Food and Drug Administration approved Otezla, a new oral therapy to treat active psoriatic arthritis in adult patients, Avella Specialty Pharmacy on Friday announced that it is prepared to begin distributing the drug.

PHOENIX — Just days after the Food and Drug Administration approved Otezla, a new oral therapy to treat active psoriatic arthritis in adult patients, Avella Specialty Pharmacy on Friday announced that it is prepared to begin distributing the drug. 

At this time, Avella is one of a select number of pharmacies that are contracted by Celgene, the drug manufacturer, to dispense the product at launch.

March 31, 2014

The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years.

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years. This is the first FDA approval of a drug for migraine prevention in this age group. 

The medication is taken on a daily basis to reduce the frequency of migraine headaches.

Topamax was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.

March 31, 2014

The Food and Drug Administration on Friday approved over-the-counter Nexium 24HR (esomeprazole 20mg), Pfizer announced.

NEW YORK — The Food and Drug Administration on Friday approved over-the-counter Nexium 24HR (esomeprazole 20mg), Pfizer announced. 

“Switching medicines, whenever appropriate, from prescription to non-prescription status improves access, empowers consumers to care for their own health and is an important strategy for Pfizer,” stated Paul Sturman, president, Pfizer Consumer Healthcare. “The FDA approval of Nexium 24HR is a significant milestone in executing against our plan.”

March 31, 2014

Greenstone announced the introduction of Piroxicam capsules to its generic pharmaceutical product line. The drug is offered in dosage strengths of 10 mg and 20 mg, and is the generic equivalent to Feldene.

PEAPACK, N.J. — Greenstone announced the introduction of Piroxicam capsules to its generic pharmaceutical product line. The drug is offered in dosage strengths of 10 mg and 20 mg, and is the generic equivalent to Feldene.

Piroxicam is intended for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. This new, authorized generic adds to Greenstone’s growing line of products, and is backed by the distribution and customer service support of Pfizer Inc., the company said.

 

March 28, 2014

Dr. Reddy's Labs announced that it has launched amlodipine besylate and atorvastatin calcium tablets, a generic version of Caduet.

HYDERABAD, India — Dr. Reddy's Labs announced that it has launched amlodipine besylate and atorvastatin calcium tablets, a generic version of Caduet.

The Caduet tablets brand and generic had sales in the United States of approximately $163 million MAT for the most recent 12 months ended January 2014, according to IMS Health.

March 28, 2014

Sandoz announced the U.S. launch of lansoprazole capsules amoxicillin capsules, USP, and clarithromycin tablets, USP, the generic version of Prevpac.

PRINCETON, N.J. — Sandoz announced the U.S. launch of lansoprazole capsules amoxicillin capsules, USP, and clarithromycin tablets, USP, the generic version of Prevpac.

The drug is used to eliminate the H. pylori infection in patients with duodenal ulcer disease. It's comprised of amoxicillin and clarithromycin, which are antibiotic medicines, as well as lansoprazole, a proton pump inhibitor that helps decrease production of excess stomach acid, the company said.

March 27, 2014

Mission Pharmacal Company on Thursday announced the availability of a new, patented dual-iron version of its prenatal vitamin, CitraNatal Harmony, a single-pill prescription supplement with calcium citrate.

SAN ANTONIO— Mission Pharmacal Company on Thursday announced the availability of a new, patented dual-iron version of its prenatal vitamin, CitraNatal Harmony, a single-pill prescription supplement with calcium citrate. The product features Ferr-Ease, a patented blend of ferrous fumarate, a rapidly absorbing iron salt, and carbonyl iron, known for its gentle, prolonged absorption.  

March 26, 2014

Actavis and Valeant Pharmaceuticals International announced that the Food and Drug Administration approved the new drug application for Metronidazole 1.3% vaginal gel. The antibiotic is used for the treatment of bacterial vaginosis, an infection caused by an imbalance in the normal bacteria of vagina.

DUBLIN and LAVAL, Quebec — Actavis and Valeant Pharmaceuticals International announced that the Food and Drug Administration approved the new drug application for Metronidazole 1.3% vaginal gel.

The antibiotic is used for the treatment of bacterial vaginosis, an infection caused by an imbalance in the normal bacteria of vagina. It's the most common vaginal infection in women ages 15 years to 44 years. Metronidazole 1.3% provides a single-dose treatment that is packaged in a pre-filled disposable applicator.

March 26, 2014

Drive Medical on Tuesday introduced the Bariatric Rollator walker.

PORT WASHINGTON, N.Y. — Drive Medical on Tuesday introduced the Bariatric Rollator walker.

The Bariatric Rollator features a 400-pound weight capacity and is extra-wide between the handles for more comfortable use. The 8-inch wheels are designed for both indoor and outdoor use. And the Bariatric Rollator includes a basket for carrying items. 

Other features include a soft padded oversized seat and a tool-free removable padded backrest for comfort.

March 26, 2014

Perrigo announced that its Nutritionals segment is partnering with KanPak to manufacture store brand adult nutritional drinks comparable to Ensure products.

DUBLIN — Perrigo on Wednesday announced that its Nutritionals segment is partnering with KanPak to manufacture store brand adult nutritional drinks comparable to Ensure products. KanPak is a supplier of beverages and desserts using aseptic processing technology. 

March 26, 2014

Zarbee's Naturals launched Seasonal Relief with Ze339, an extract from Butterbur that helps relieve congestion, the company reported.

SALT LAKE CITY — Zarbee's Naturals on Tuesday launched Seasonal Relief with Ze339, an extract from Butterbur that helps relieve congestion, the company reported. 

March 24, 2014

Genentech announced that the Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, or CIU, which is a form of chronic hives.

SOUTH SAN FRANCISCO, Calif. — Genentech announced that the Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, or CIU, which is a form of chronic hives.

CIU is diagnosed when hives occur without cause, spontaneously present and reoccur for more than six weeks, the company said. The symptoms include swelling, severe itch, pain and discomfort that may last for months and, in some cases, years. 

March 24, 2014

Celgene on Friday announced that the Food and Drug Administration has approved Otezla (apremilast), the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis.

SUMMIT, N.J. — Celgene on Friday announced that the Food and Drug Administration has approved Otezla (apremilast), the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis. A chronic disorder, psoriatic arthritis is characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning. Otezla is the only FDA-approved oral treatment for psoriatic arthritis.

March 21, 2014

Pharma Major Lupin announced that Lupin Pharmaceuticals, its U.S. subsidiary, has launched niacin extended-release tablets USP in 500-mg, 750-mg and 1,000-mg strengths.

MUMBAI and BALTIMORE — Pharma Major Lupin announced that Lupin Pharmaceuticals, its U.S. subsidiary, has launched niacin extended-release tablets USP in 500-mg, 750-mg and 1,000-mg strengths.

The drug is the generic version of AbbVie’s Niaspan tablets. It's used to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia, the company said.

March 21, 2014

Danish pharmaceutical group Alk Abello, in association with Merck, expects to start selling its new dust mite allergy tablet in the United States in 2017, according to a Reuters report published Thursday.

NEW YORK — Danish pharmaceutical group Alk Abello, in association with Merck, expects to start selling its new dust mite allergy tablet in the United States in 2017, according to a Reuters report published Thursday

House dust mite-allergy is associated with allergic asthma and affects more than 30 million Americans.

March 21, 2014

Skinnygirl brand has already made its foray into several categories, including a recent line of water flavor enhancers and a partnership with SodaStream to create new flavors. Now the brand will step into the supplement category with its new Skinnygirl Supplements.

NEW YORK — Skinnygirl brand has already made its foray into several categories, including a recent line of water flavor enhancers and a partnership with SodaStream to create new flavors. Now the brand will step into the supplement category with its new Skinnygirl Supplements.

March 20, 2014

The Food and Drug Administration announced the approval of Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Leishmaniasis is caused by Leishmania, a parasite transmitted to humans through sand fly bites.

SILVER SPRING, Md. — The Food and Drug Administration announced the approval of Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Leishmaniasis is caused by Leishmania, a parasite transmitted to humans through sand fly bites. It's the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.

March 19, 2014

Heel Inc., a homeopathic pharmaceutical company, announced the debut of ClearLife allergy relief and WellMind calming and alertness aid brands.

ALBUQUERQUE, NM — Heel Inc., a homeopathic pharmaceutical company, announced the debut of ClearLife allergy relief and WellMind calming and alertness aid brands.

The ClearLife line melds three of the company's allergy relief products under a single brand: ClearLife Nasal Spray (previously sold as Luffeel), ClearLife Tablets (previously sold as Adrisin) and ClearLife Eye Drops (previously sold as Oculoheel). The new packaging includes green branding and comes with a manufacturer's suggested retail price of $11.99.

 

March 18, 2014

Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.

DUBLIN — Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.

The drug also is indicated for patients for whom alternative treatments have shown to be ineffective. Xartemis XR, previously known as MNK-795, is the first and only extended-release oral combination of two clinically proven pain medications — oxycodone and acetaminophen.