Femcon Fe (Warner Chilcott) is being advertised as the world's only chewable oral contraceptive. It was formerly marketed as Ovcon 35 Fe. Each packet provides 21 tablets containing 0.4 mg norethindrone and 35 mcg ethinyl estradiol, and 7 tablets with only 75 mg of ferrous fumarate. Femcon Fe has the same active hormonal ingredients as Ovcon 35 (Warner Chilcott), which has been available since 1976, and its generic equivalent Balziva (Barr); neither formulation contains iron. The spearmint-flavored Femcon Fe pill can be chewed or swallowed whole. According to the package labeling, if the pill...

The FDA has approved calcitriol ointment (Vectical - Galderma), a vitamin D analog, for topical treatment of mild-to-moderate plaque psoriasis in adults ≥18 years old. Ointments are generally considered more potent than creams or solutions.

Combination oral contraceptives increase the risk of venous thromboembolism (VTE). Their benefits, in addition to preventing pregnancy, include lowering the risk of ovarian and endometrial cancer, reducing dysfunctional uterine bleeding and increasing serum hemoglobin concentrations. Are these benefits worth the risk? And are some combination oral contraceptives safer than others?

The FDA has approved pralatrexate (Folotyn – Allos), an intravenous (IV) antifolate, for treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the first drug approved by the FDA specifically for this indication.

The FDA has approved an extended-release oral formulation of the opioid agonist hydrocodone (Zohydro ER – Zogenix) for management of pain severe enough to require continuous, long-term therapy and for which alternative treatment options are inadequate. Zohydro ER is the first single-ingredient hydrocodone product to be marketed in the US. Hydrocodone has been available for years in combination with acetaminophen (Vicodin, and others) or ibuprofen (Vicoprofen, and others).

Ramucirumab (Cyramza – Lilly), a monoclonal antibody that inhibits vascular endothelial growth factor receptor 2 (VEGFR2), has been approved by the FDA for use as monotherapy or in combination with paclitaxel for treatment of advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after platinum- or fluoropyrimidine-based chemotherapy. Ramucirumab is also approved for use in combination with docetaxel (Taxotere, and others) for treatment of metastatic non-small cell lung cancer that has progressed on or after platinum-based...

The FDA has approved Prestalia (Symplmed), an oral fixed-dose combination of the dihydropyridine calcium channel blocker amlodipine (Norvasc, and generics) and a new salt form of the angiotensin-converting enzyme (ACE) inhibitor perindopril, for treatment of hypertension in patients not adequately controlled on monotherapy or already taking both drugs, and in those just starting therapy who are likely to need multiple drugs to control their blood pressure. The new salt form (perindopril arginine) is more stable and has a longer shelf-life than perindopril erbumine (Aceon, and...

The FDA has approved anthrax vaccine adsorbed (AVA; BioThrax – Emergent BioSolutions) for prevention of anthrax disease in adults following exposure to Bacillus anthracis and intravenous anthrax immune globulin (Anthrasil – Emergent BioSolutions) for treatment of inhalation anthrax in adults and children. AVA has been available since 1970 for prevention of anthrax disease in persons at high risk of exposure.

Brivaracetam (Briviact – UCB), an analog of levetiracetam (Keppra, and others), has been approved by the FDA for adjunctive treatment of partial-onset seizures in patients ≥16 years old. New drugs for epilepsy are often approved initially only as adjunctive treatment for partial seizures.

The FDA has approved Roxybond (Daiichi Sankyo), an short-acting (SA) oxycodone formulation with abuse-deterrent properties, for treatment of pain requiring management with an opioid. Roxybond is the first SA opioid to be approved as an abuse-deterrent product. Oxaydo, another IR oxycodone formulation, has properties that discourage its intranasal and intravenous use, but is not considered an abuse-deterrent product by the FDA. Use of opioids for treatment of pain was reviewed in a recent issue.